221 Jobs für Merck in Deutschland

Quality Assurance

Erfurt, Thüringen €60000 - €90000 Y Sonova Group

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Arbeitsbeschreibung

Dein Beitrag:
Als
Qualitätsmanagementbeauftragter
stellst Du sicher, dass unsere hohen Qualitätsstandards eingehalten werden und die Qualitätskultur am Standort gelebt wird. Du trägst dazu bei, die Produktkonformität zu gewährleisten und den erfolgreichen Marktzugang abzusichern.

Das sind deine Aufgaben:

  • Du bist zentraler Ansprechpartner für das lokale Management und als Teil der mittleren Führungsebene ein wichtiger Sparringspartner für die Standortleitung.
  • Du bist für die Qualitätssicherungsmaßnahmen auf dem Shopfloor verantwortlich und sorgst dafür, dass die Qualitätskultur am gesamten Standort gelebt wird.
  • Du bist verantwortlich für die Produktkonformität und unterstützt die Zertifizierungsaktivitäten zur Sicherstellung eines erfolgreichen Marktzugangs.
  • Du entwickelst, implementierst und steuerst das Qualitätsmanagementsystem auf der Grundlage der ISO 13485, ISO 14001 sowie ISO 9001.
  • Gemeinsam mit dem Management Team erarbeitest Du entsprechende Prozessbeschreibungen, Richtlinien und Vorgaben.
  • Du übernimmst die Dokumentation und Kommunikation des QMS.
  • Du stellst die Einhaltung der QM-Standards sicher und führst dazu regelmäßige interne Audits durch, dabei leitest du Korrektur- und Vorbeugemaßnahmen ein.
  • Bei der Erstellung von QM relevanten Dokumenten übernimmst du die Koordination sowie Überwachung und unterstützt die Kollegen im konformen Umgang mit Dokumenten.
  • Du planst, initiierst und koordinierst interne QM–Projekte sowie funktionsübergreifende Arbeitsgruppen.
  • Du übernimmst das Qualitätscontrolling und greifst dabei sicher auf Qualitätsrelevante KPI's zurück.
  • Planung und Durchführung von Schulungen von Kollegen.

Das ist dein Profil:

  • Du hast ein abgeschlossenes Studium in den Bereichen Ingenieurwesen, Technik oder Qualitätsmanagement.
  • Du hast mehrjährige Erfahrung im Qualitätsmanagement einer regulierten Industrie mit Schwerpunkt auf ISO 9001. Kenntnisse der ISO 13485 und ISO 14001 sind von Vorteil.
  • Du hast bereits Erfahrungen mit den Anforderungen der Good Manufacturing Practice und Good Distribution Practice.
  • Du verfügst über sehr gute Projekt- und Prozessmanagement Qualitäten.
  • Du bist kommunikations-, moderationsstark und bringst ausgereifte Methodenkompetenz mit.
  • Sehr gute Deutsch- und Englischkenntnisse runden dein Profil ab.

Von Vorteil sind:

  • Erfahrung im Qualitätsmanagement in der Medizintechnikbranche.
  • Kenntnisse in SAP im Zusammenhang mit Qualitätsmanagement.

Klingt nach dir?
Magdalena Suszek, Talent Acquisition Partner, freut sich darauf, Deine vollständige Bewerbung über unsere Online-Jobplattform zu erhalten. Für diese Stelle werden nur Direktbewerbungen berücksichtigt.

Wir hören uns
Sonova is an equal opportunity employer.
We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.

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Quality Assurance

München, Bayern €60000 - €90000 Y FAST LTA GmbH

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Arbeitsbeschreibung

Kurzinfo

Bist du ein qualitätsverliebter Tüftler (w/m/d) mit Spaß daran, Systeme wirklich "kaputt zu testen" – und sie dadurch besser zu machen? Du möchtest ein QA‑Framework von Grund aufbauen, bestehende Strukturen klug nutzen und zugleich mutig neue Wege gehen? Wenn du Lust auf eine Schnittstellenrolle zwischen unserem AI‑Team und der bestehenden Quality Assurance Abteilung hast, bist du bei uns genau richtig.

Über FAST LTA & Silent AI

FAST LTA ist deutscher Technologieführer für Zero‑Loss‑Storage und Off‑Cloud‑Appliances. Mit Silent AI bringen wir eine komplett lokale KI‑Plattform auf dedizierter Hardware in die Rechenzentren unserer Kunden – 100 % local, 100 % secure, 100 % yours.

Das sind deine Aufgaben:

Dein Playground

  • QA‑Strategie & Framework: Teststrategie definieren (Unit, API, E2E, Performance, Security), Toolchain auswählen, ein skalierbares Automations‑Framework aufbauen, wiederverwendbare Test‑Libraries entwickeln, Quality‑Gates definieren und in CI/CD integrieren.
  • Testautomation & Infrastruktur: Autotests unter Linux selbst schreiben, API‑/SDK‑Tests, System‑ und Appliance‑Tests inkl. Hardware‑in‑the‑Loop, Testumgebungen mit Docker bereitstellen, Testdaten‑Management & Fixtures, Umgang mit GPUs und Inference‑Pipelines.
  • Schnittstelle AI und QA: Anforderungen aus dem AI‑Team (LLM/RAG‑Pipelines, Model‑Serving, Konnektoren) aufnehmen, präzise Akzeptanzkriterien definieren, Contract‑/Integrationstests etablieren, eng mit der bestehenden QA abstimmen und Prozesse harmonisieren.
  • Testmanagement & Transparenz: Testpläne und ‑fälle in Tools wie Zephyr, Xray, TestRail oder TestPlan pflegen, Kennzahlen (Coverage, Flakiness, Stabilität, DORA‑relevante Metriken) erheben, aussagekräftige Reports und Release‑Go/No‑Go‑Empfehlungen geben.
  • Nicht‑funktionale Qualität: Last‑/Performance‑Tests (Durchsatz/Latenz bei Inference), Robustheit & Zuverlässigkeit, Upgrade‑/Rollback‑Szenarien, Ausfallsimulation/Chaos‑Tests, Security‑Checks für air‑gapped Umgebungen, Backup/Restore‑Szenarien (Zero‑Loss‑Anspruch).
  • Release & Compliance: Definition of Done und Quality‑Gates je Komponente, Traceability (Anforderung vonTest hin zum Ergebnis), Dokumentation für Audits.
Das bringst du mit:
  • Technisch sattelfest: Studium (Informatik, Elektro‑/Wirtschaftsingenieurwesen o. ä.) oder vergleichbare Praxis.
  • QA‑DNA: >3 Jahre Erfahrung in Testautomation & Framework‑Aufbau – idealerweise in Backend/Infra/Appliance‑Umfeldern, gerne mit AI‑Bezug.
  • Linux & Python: sicher im Shell‑Workflow, Python für Tests/Tools (pytest), Grundwissen zu Netzwerken/Protokollen (HTTP, TLS, gRPC, REST).
  • QA‑Tools: tiefe Erfahrung mit Zephyr, TestPlan, Xray oder TestRail; Ticketing/Jira sicher im Griff; sauberes Versionieren von Testartefakten (Git).
  • CI/CD & Ops: Routine mit GitLab CI/Jenkins, Container (Docker), Artifactory/Registry, Observability (Logs/Metriken, z. B. ELK/Prometheus/Grafana) als Bonus.
  • Kommunikation & Ownership: du übersetzt Technik in klare Qualitätskriterien, moderierst zwischen AI‑Team, QA und Product, arbeitest strukturiert, transparent und lieferst inkrementell.
  • Sprachen: fließend Deutsch + Englisch

Nice‑to‑have (kein Muss):

  • Erfahrung mit AI/ML‑Systemtests (LLM/RAG, vLLM, Embeddings, Vektorsuche)
  • Hardware‑nähe (GPUs, Appliances)
  • Security/Compliance (z. B. Common Criteria/EAL)
  • zusätzliche Sprachen (TypeScript)
Das bieten wir:
  • Flexibles Arbeiten – flexible Home-Office Tage nach Einarbeitung möglich
  • Sport & Gesundheit – Wöchentliche Sporteinheiten mit externen Trainern (Yoga, Pilates, Selbstverteidigung & mehr)
  • Zukunftssicherheit – Betriebliche Altersvorsorge (ETF basiert) für deine finanzielle Absicherung mit 30 % Arbeitgeberzuschuss
  • Team-Events – Firmen-Wiesn, Weihnachtsfeier, gemeinsame Betriebsausflüge
  • Mobilität – JobRad-Programm nach der Probezeit, kostenlose Parkplätze & E-Auto-Ladestationen
  • Afterwork & Spaß – Regelmäßige Events mit frisch gezapftem Bier (im Sommer auf der Dachterrasse)
  • Familienfreundlich – Zuschüsse zur Geburtsbeihilfe & Kinderbetreuung
Ansprechpartner*in

Du sorgst dafür, dass Silent AI zuverlässig, reproduzierbar und auditierbar beim Kunden läuft – und hebst die Qualitätslatte für unsere gesamte Plattform. Deine Arbeit macht den Unterschied zwischen "funktioniert irgendwie" und "funktioniert immer".

Klingt gut? Schick uns deinen Lebenslauf oder dein aussagekräftiges LinkedIn‑Profil – und wenn vorhanden, Beispiele für Testframeworks/Repos, auf die du stolz bist. Wir freuen uns auf dich

Über uns
Hallo.

wir sind die FAST LTA GmbH aus München und wir entwickeln und vermarkten Technologien sowie Produkte zur sicheren Langzeitspeicherung digitaler Daten. Wir sind Marktführer in Deutschland für revisionssicheren Speicher für Krankenhäuser und öffentliche Verwaltungen. Zu unseren Kunden zählen namhafte Unternehmen aus der Industrie.

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Quality Assurance

Tuttlingen, Baden Württemberg EPM Scientific

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Arbeitsbeschreibung

Job Description

Quality Engineers - Medical Device Manufacturing Project (Freiburg Area

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Quality Assurance Expert

Frankfurt am Main, Hessen €60000 - €100000 Y Merck KGaA

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Arbeitsbeschreibung

Job Id

Darmstadt, Hessen, Germany

Job Type

full-time, part-time possible

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role

As a member of the Site Quality Darmstadt Development team, you will be responsible as Quality Assurance Expert to support the go-live and routine manufacturing in the Technical Development Center at Darmstadt site for parenteral products intended for clinical studies.

In this role you will oversee all manufacturing relevant GMP processes, review and approve the relevant SOPs, perform batch record review including aseptic process validation runs and prepare the product batch documentation for the release step by QP, act as shop floor QA in the plant and be involved in deviation and change control management.

You support the implementation of new parenteral products in the Technical Development Center overseeing local quality requirements.

Further responsibilities include assurance of compliance of processes and products with regulatory requirements and quality standards, including communication with internal and global interfaces in Healthcare Quality.

It will be part of your duties to support site related audits and inspections by competent authorities as well as self-inspections on site.

Who you are:

  • Master in Biology, Chemistry other Scientific discipline or adequate professional experience or Approbation as pharmacist
  • 3+ years of operating experience in pharmaceutical GMP manufacturing of parenteral products
  • 2+ years of experience in pharmaceutical development environment
  • Experience in monitoring and evaluation of sterile manufacturing processes
  • Know-how of electronic document management systems (Mango, Trackwise, etc.) as well as electronic manufacturing execution systems (MES/ERP)
  • Experience with methods and concepts of pharmaceutical quality systems
  • Knowledge of governmental regulatory guidelines and regulations relating to the manufacturing of pharmaceuticals
  • Fluent in German and English
  • Strong ability to communicate even in challenging situations, team oriented, outcome-oriented personality

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity

US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Notice on Fraudulent Job Offers

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information here.

Applicant Profile

Along with our brand-new career site, we've also revamped our application process. If you've applied for a position before April 16th 2025, you can log into your old profile to see the status of past applications. For the application you've will completed, and any in the future, you can create a new profile to check in on your status.

WHAT WE OFFER

Money makes the world go round. But at our company there's more than just financial rewards. We offer a range of attractive benefits to help you work your magic.

Saving & Finacial

Our 401(k) Plan includes a generous company-matching contribution and an additional discretionary contribution each year.

We also provide tax-advantaged accounts for you to save for healthcare, commuting expenses, company-provided and buy-up life insurance to help you protect your financial future.

Health & Wellness

We offer comprehensive medical, dental, & vision coverage-including virtual care through Telehealth & free behavioral health counseling sessions through our Employee Assistance Program.

We also offer a wellness incentive program and personalized support to help you navigate and use your benefits.

Voluntary Benefits

Our voluntary benefits provide additional protection from the high costs of healthcare not covered by health insurance.

We also have discount programs that offer exclusive savings on everything from auto, home, and pet insurance to low-interest personal loans.

Work/Life Support

We have several programs to support your work/life balance, including generous paid time off, back-up day care services, education assistance, and more.

OUR RECRUITING PROCESS

Depending on the position (level, functional area, country) the process can vary slightly.

You apply

Complete your online application for your preferred role(s) that match your interests and qualification. If you cannot find a suitable role please join our Talent Zone and stay connected for your next career opportunity.

We screen

We review your application and if we determine that you are a good fit we will move you to the selection process.

We assess

You are interviewed by phone, via video and/or face to face.

Mutual agreement

Ideally you are the perfect match for us We hope you consider us as your new employer.

Work your magic

To guarantee you a smooth start our onboarding preparation begins.

Haven't found the right job yet?

Join our Talent Community to stay connected and explore future opportunities.

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Quality Assurance Tester

Pertemps ERP

Vor 9 Tagen gepostet

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Arbeitsbeschreibung

employee

Adobe AEM QA Tester – Manufacturing Industry

Permanent, English only

Location: Prague

We’re seeking an Adobe QA Tester to ensure the quality of the Adobe Experience Manager (AEM), Adobe Campaign, and digital solutions in the manufacturing sector of a large international company . You'll work with cross-functional teams to optimize customer engagement, automate testing, and enhance digital platforms for industrial operations.

Tasks

5+ years of QA experience with Adobe marketing products

Expertise in test automation (Selenium, JUnit, TestNG) & performance testing

Experience in manufacturing software integrations (ERP, CRM, PLM)

Knowledge of CI/CD pipelines (Jenkins, Bamboo) & cloud platforms (AWS, Azure)

Adobe Certified Expert (ACE) is a plus

Requirements

Global leader in manufacturing & industrial technology

Impact real-world industrial solutions

Growth opportunities & certification support

Work with cutting-edge Adobe tech

Benefits

Benefits

Medical, dental, vision insurance

401(k) with employer matching

Tuition reimbursement & career development

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Quality Assurance Specialist

28918 Altum Sequencing

Vor 14 Tagen gepostet

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Arbeitsbeschreibung

employee

At Altum Sequencing, we are dedicated to transforming cancer diagnostics and monitoring through cutting-edge genomic technologies. As Quality Assurance Specialist your mission is to establish, implement, and continuous improve of a robust Quality Management System (QMS) aligned with UNE-EN ISO 15189 and UNE-EN ISO 13485, supporting medical device development activities (IVD) at Altum Sequencing.

The QA Specialist will play a key role in the implementation of ISO 13485 of in vitro diagnostic products, enabling the company to deliver reliable, compliant, and high-quality solutions to patients and clinical partners.

Tasks

Roles and Responsibilities:

Quality Management System (QMS) and Compliance and Accreditation:

  • Implement and maintain the Quality Management System (QMS) following ISO 13485, IVDR and ISO 15189 standards.
  • Support the company in the certification process for ISO 13485 for in vitro diagnostic products.
  • Ensure documents, procedures, and records are up to date and compliant with regulatory requirements.
  • Collaborate in internal audits, follow up on non-conformities, and support corrective and preventive actions (CAPA).
  • Work closely with Regulatory Affairs, R&D, Laboratory, and external partners to ensure quality is present in all processes.

Process and Risk Management:

  • Identify, assess and mitigate risks that could affect the quality of laboratory results.
  • Support process improvements through quality planning, risk analysis and statistical monitoring.

Training and Competence:

  • Organize training related to quality and ensure personnel competence is documented and up to date.
  • Promote a culture of quality and continuous improvement across all teams.

Quality Data Management:

  • Track, analyze and report quality metrics e.g. open/closed/overdue Non-Conformities, CAPA, customer Complaints, Change Controls and Documentation.
  • Monitor performance indicators and initiate quality improvement initiatives as needed.

Client and Stakeholder Communication:

  • Address quality-related client concerns or complaints professionally and promptly.
  • Ensure clients and collaborators receive high-quality, validated and reproducible laboratory data.
Requirements
  • Bachelor's or Master's degree in Life Sciences, Biotechnology, Pharmacy, Engineering or related field.
  • Minimum 3–5 years of experience in QA roles within clinical laboratories, medical device companies or biotechnology environments.
  • Proven knowledge and hands-on experience with ISO 13485, IVDR, ISO 15189, and GDPR (General Data Protection Regulation) and GCP (Good Clinical Practices).
  • Excellent organizational, problem-solving, documentation and communication skills.
  • Experience with audit preparation and CAPA systems.
  • Proficiency in quality software tools and document control systems.
Benefits
  • Mission-Driven Impact – Be part of a team fighting cancer through cutting-edge liquid biopsy and MRD technologies.
  • Deep Tech Environment – Collaborate with top scientists and engineers at the forefront of bioinformatics and NGS innovation.
  • Flexible Work Setup – Hybrid and remote options available, with core hours adapted to scientific workflows.
  • Continuous Learning – Access to conferences, courses, and internal knowledge-sharing sessions.
  • Collaborative Culture – Work cross-functionally with clinical, R&D, and product teams in a fast-growing startup.

At Altum Sequencing , we believe that our people are our most valuable asset. We are committed to creating a purpose-driven, inclusive, and rewarding environment where scientific talent can thrive and contribute to real impact in patients’ lives. As a member of our team, you will benefit from:

Mission-Driven Work

  • Be part of a cutting-edge company focused on transforming cancer care through precision diagnostics and real-time MRD monitoring.
  • Contribute to meaningful projects that directly impact clinical decisions and patient outcomes.

Professional Growth & Development

  • Work in a multidisciplinary, innovation-driven environment where learning and collaboration are at the core.
  • Access to internal and external training opportunities, including certifications, conferences, and scientific development.
  • Defined career progression pathways, with the opportunity to take on increasing responsibility and leadership.

Modern, Dynamic Workplace

  • A fast-paced biotech start-up culture with a strong focus on agility, creativity, and teamwork.
  • Access to state-of-the-art laboratory infrastructure and technologies, including advanced NGS platforms and automation systems.

Inclusive & Collaborative Culture

  • Flat organizational structure that encourages ownership, open communication, and idea-sharing.
  • A supportive team where your voice is heard and your contributions are recognized.

Stability with Flexibility

  • Competitive salary package, aligned with your experience and the impact of your role.
  • Flexible working hours.
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Lead Quality Assurance Engineer

47137 Duisburg, Nordrhein Westfalen WhatJobs

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Arbeitsbeschreibung

full-time
Unser Klient ist ein renommiertes Produktionsunternehmen und sucht für seinen Standort in **Duisburg, Nordrhein-Westfalen, DE**, einen erfahrenen und qualifizierten Lead Quality Assurance Engineer. Sie sind verantwortlich für die Entwicklung, Implementierung und Überwachung von Qualitätsmanagementstrategien, um sicherzustellen, dass unsere Produkte und Prozesse den höchsten Industriestandards entsprechen. In dieser Schlüsselrolle leiten Sie ein Team von QA-Spezialisten und arbeiten eng mit Produktions-, Entwicklungs- und Einkaufsteams zusammen, um kontinuierliche Verbesserungen zu erzielen und die Kundenzufriedenheit zu gewährleisten.

Ihre Verantwortlichkeiten umfassen:
  • Entwicklung und Implementierung umfassender Qualitätsmanagementpläne und -verfahren.
  • Leitung und Mentoring des Quality Assurance Teams, einschließlich Schulung und Leistungsmanagement.
  • Durchführung regelmäßiger interner Audits zur Überprüfung der Einhaltung von Qualitätsstandards und -vorschriften.
  • Identifizierung von Verbesserungspotenzialen in Produktionsprozessen und Entwicklung von Korrekturmaßnahmen.
  • Überwachung und Analyse von Qualitätsdaten zur Identifizierung von Trends und zur Erstellung von Berichten.
  • Sicherstellung der Einhaltung relevanter Normen und Zertifizierungen (z. B. ISO 9001).
  • Zusammenarbeit mit Lieferanten, um sicherzustellen, dass eingehende Materialien unseren Qualitätsanforderungen entsprechen.
  • Fehleranalysen und Ursachenforschung bei Produktmängeln.
  • Schaffung einer Qualitätskultur im gesamten Unternehmen.

Ihr Profil:
  • Abgeschlossenes Studium im Ingenieurwesen, idealerweise Maschinenbau, Wirtschaftsingenieurwesen oder verwandten Fachrichtungen.
  • Mehrjährige Berufserfahrung im Qualitätsmanagement in der produzierenden Industrie.
  • Nachweisliche Erfahrung in der Leitung von Teams.
  • Fundierte Kenntnisse von Qualitätsmanagementnormen und -methoden (z. B. Six Sigma, Lean Manufacturing).
  • Ausgeprägte analytische Fähigkeiten und eine systematische Herangehensweise an Problemlösungen.
  • Sehr gute Kommunikationsfähigkeiten in Deutsch und Englisch.
  • Hohe Reisebereitschaft für Audits und Lieferantenbesuche.

Wir bieten eine anspruchsvolle und abwechslungsreiche Tätigkeit in einem dynamischen Umfeld mit attraktiven Karriereentwicklungsmöglichkeiten. Werden Sie Teil unseres engagierten Teams und gestalten Sie aktiv die Zukunft unserer Produktqualität mit.
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Über das Neueste Merck Jobs In Deutschland !

Senior Specialist Quality Assurance

Berlin, Berlin €90000 - €120000 Y CHEPLAPHARM

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Arbeitsbeschreibung

We are a global and growing speciality pharmaceutical company with an exceptional, sustainable business model.
Our mission
: to be THE platform for established and trusted branded products in various therapeutic areas and indications and to ensure their availability in the highest quality as an important partner of the innovation-driven pharmaceutical industry for the global market

We have a common goal: to improve people's health and lives. That's why we don't think in terms of quick effects, but want to
achieve more
with our actions - in the long term and reliably.

All of this is only possible with people who don't just do their job, but want to achieve something themselves. We are so successful because we develop and encourage our colleagues and give them the freedom and flexibility they need for their daily work.

Your Responsibility
Quality Oversight & Compliance

  • Provide quality leadership and oversight for products manufactured at external sites. Ensure CMOs comply with GMP, global regulatory requirements, and company quality standards
  • Conduct risk assessments, deviation investigations, and approve CAPAs (Corrective & Preventive Actions)
  • Lead or support audits and inspections (regulatory, corporate, and customer)
  • Act as the primary quality interface between the company and assigned CMOs
  • Monitor and evaluate performance of external partners through KPIs and periodic reviews
  • Review and approve technical/quality agreements, manufacturing documents, and change controls
  • Oversee review and approval of batch records, validation reports, and quality documentation
  • Drive quality improvements at external sites to enhance efficiency, compliance, and reliability
  • Identify risks in supply chain and manufacturing processes; develop and implement mitigation strategies
  • Support implementation of Quality Management System (QMS) enhancements across CMOs
  • Partner with Regulatory Affairs, Supply Chain, and other functions for product lifecycle management
  • Provide expert quality input for technology transfers and validation activities
  • Support inspections and responses to authorities

Your Profile

  • You have successfully completed a degree with a relevant focus (e.g., Pharmacy, Chemistry, Biotechnology, Life Sciences, or similar) or hold a comparable qualified education
  • You have at least 10 years of experience in the pharmaceutical industry, including at least 5 years in Quality Assurance, Quality Compliance, or External Quality. You bring extensive experience in managing external manufacturing organizations (CMOs/CDMOs)
  • You possess solid knowledge of ICH, FDA, EMA, GMP, GDP, and other international regulatory requirements and you also have demonstrable expertise in audits, deviation management, CAPA, and QMS processes, as well as proven success in supporting regulatory inspections (e.g., FDA, EMA)
  • Your communication, negotiation, and stakeholder-management skills are excellent and you work effectively in a matrix and multicultural environment
  • Your work style combines the ability to align compliance requirements with business needs, high attention to detail, and a strong commitment to quality
  • You combine strategic thinking with a hands-on approach
  • You speak fluent English and German at least at level B1 or better.
  • Additionally, you have solid MS Office skills and ideally experience with SAP

Our Offer

  • A growing company with a diverse and open-minded working environment with employees from around 40 different countries
  • Flexible working models adapted to your needs (e.g. up to 100% remote working and up to two months from abroad within the EU possible), working time account with time off in lieu, 30 days' holiday
  • Flexible benefits budget that you can use according to your individual preferences, such as a higher employer contribution to the company pension scheme, fitness & health offers or subsidies for travel or meal costs. E.g. higher employer contribution to the company pension scheme, fitness & health offers or subsidies for travel or catering costs
  • Discounts at hundreds of partner companies through access to the corporate benefits platform
  • Internal and external training courses, tailored to your personal goals
  • Company and team events to build relationships outside of the workplace and celebrate successes together

We look forward to receiving your detailed application Please only use the "
Apply now
" function for your application.

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Product Quality Assurance Manager

Munich, Bayern Nuna

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Arbeitsbeschreibung

Job Description

About the job

We are a leading global brand dedicated to creating Smart, Helpful, and Bold baby gear since 2007. Our business has continued to grow exponentially, and we are seeking an experienced and analytical Product Quality Assurance Manager (m/f/d) with a focus on post-market compliance activities. In this key role, you will handle product-related issues that occur after market launch, including customer complaints, regulatory inquiries, quality issues, and field feedback—and ensure they are effectively processed and integrated into our compliance management system.


You will act as a central point of contact for our European subsidiaries and distributor markets in the EU and UK, ensuring that post-market events are addressed efficiently, transparently, and in full alignment with regulatory obligations and internal standards.


What you'll do

1. Post-Market Event Management

  • Manage post-market compliance events such as customer complaints, product performance issues, and field incidents.
  • Oversee documentation, tracking, and evaluation of post-market events in the Compliance Management System (CMS).
  • Identify trends and recurring issues from market feedback and initiate preventive/corrective measures.


2. Regulatory Liaison & Compliance Oversight

  • Act as primary liaison for national market surveillance authorities (e.g. Gewerbeaufsichtsämter) and regulatory bodies in the EU and UK.
  • Ensure all incidents are assessed in accordance with the General Product Safety Regulation (GPSR) and applicable national laws.
  • Collaborate with external testing laboratories and certification bodies where needed to assess post-market issues.


3. Internal Collaboration & Training

  • Coordinate investigations and root cause analyses in collaboration with Quality, Product Development, and Manufacturing.
  • Provide internal training and guidance on incident handling, corrective actions, and reporting obligations.


What you'll bring

  • Degree in Engineering, Product Safety, Quality Management, Legal, or a related field.
  • 3–5 years of experience in product compliance or regulatory affairs, ideally in consumer or juvenile goods industry.
  • Fluency in English; German or other European languages are a plus.
  • Strong ability to interpret and apply EU regulations and EN standards in post-market contexts.
  • General knowledge of EU product safety (GPSR) and other EU consumer goods legislation.
  • Experience with handling regulatory authority inquiries, product complaints, and field returns.
  • High attention to detail and strong problem-solving mindset.
  • Experience working across international teams and time zones is desirable


What You’ll Get:

  • Purposeful Work: A meaningful role contributing to the safety and quality of children's products.
  • Global Scope: Central responsibility with broad international exposure across Europe and Asia.
  • Empowered Culture: Flat hierarchies, short decision-making processes, and room for your ideas.
  • Work-Life Balance: A flexible work schedule and a strong focus on work-life balance – with the mindset to give 100% when it matters.
  • Diverse & Supportive Team: Collaborate with a talented, multicultural team and learn from a wide range of professional backgrounds.
  • Professional Development: Grow your skills and career with the fast-expanding company.

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Team Lead - Quality Assurance

Hamburg, Hamburg exmox GmbH

Vor 12 Tagen gepostet

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Arbeitsbeschreibung

employee
Your mission

We’re looking for a QA Lead to take ownership of software quality across our platform. In this role, you'll lead the design and execution of our QA strategy, working closely with developers, product managers, and stakeholders to ensure that every release is reliable, bug-free, and aligned with user expectations.

Beyond hands-on testing and automation, you’ll play a key role in building and coaching a high-performing QA team. You’ll mentor engineers, foster a culture of accountability and continuous improvement, and help elevate quality practices across the entire product organization. If you're passionate about enabling others, driving excellence, and scaling quality in a collaborative environment, this role is for you.

Your key responsibilities
  • Mentor and coach QA engineers, supporting their technical growth and professional development.
  • Lead QA team meetings, coordinate testing efforts, and communicate quality status and risks to stakeholders.
  • Lead the development and execution of test plans, test cases, and automated test scripts.
  • Identify, document, and manage software defects across multiple environments and platforms.
  • Collaborate with development teams to understand product requirements and provide early, proactive feedback.
  • Drive the implementation of automated testing within our CI/CD pipelines.
  • Monitor test results, perform root cause analysis, and ensure issues are tracked and resolved efficiently.
  • Participate in code reviews and advocate for testability, quality, and clean releases.
  • Improve and scale QA methodologies, workflows, and documentation across teams.
  • Foster a culture of quality ownership and continuous improvement across cross-functional teams.
  • Partner with product and engineering leadership to align QA priorities with business goals and delivery timelines.
Your profile
  • 4 - 6 years of experience in software QA, including at least 1-2 years in a lead position.
    Strong understanding of QA principles, software testing strategies, and defect lifecycle management.
  • Hands-on experience with automated testing frameworks (e.g., Cypress, Selenium, Playwright).
  • Familiarity with CI/CD tools and processes (e.g., GitHub Actions, Jenkins, GitLab CI). Experience working in Agile/Scrum teams with cross-functional collaboration.
  • Excellent problem solving skills, attention to detail, and ownership mindset.
  • Strong communication skills and a proactive approach to working with developers and stakeholders.
  • Bachelor’s degree in Computer Science, Information Technology, or a related field.
Nice to have
  • Experience in Ad-Tech, performance marketing, or large-scale digital platforms.

If you're passionate about building reliable systems and enabling fast teams to ship with confidence, we’d love to hear from you.

Why us?
  • Work-Life Balance: 30 days of paid vacation.
  • Commuter Benefits: Public transportation tickets provided.
  • Professional Development: Annual education budget of €1,500.
  • Workation Opportunities: Combine work and vacation annually.
  • Wellness: Access to over 7,000 gyms and spas in Germany through Wellpass.
  • Catering: Monthly team lunches, daily fruits, vegetables, and a variety of beverages.
  • Flexibility: Flexible working hours and hybrid work model.
  • Corporate Benefits: Exclusive discounts for major brands and platforms.
  • Diversity: Join an international team with diverse cultural backgrounds.
  • Fun and Games: Socializing area for relaxing activities during the workday. Please note: this is not a remote only position, we offer you a flexible hybrid model here in Hamburg, Germany - working from home on Mondays & Fridays, coming to the office on Tuesday, Wednesday & Thursday! :)
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