Staff Software Quality Engineer
Jobbeschreibung
As one of the most experienced staffing firms in Denver,
Colorado, North Star Staffing Solutions prides itself on exceptional
services and relationships that we have built over the years. Our
dedication to satisfying our clients’ needs is driven by a passionate
team of dedicated staff with over 10 years of experience. We have
continued to provide the recruiting and staffing expertise our clients
expect and they have acknowledged time and again that our services are
integral to their success. Our mission is to bring great people and
great organizations together. This is the foundation that has made us
who we are today. We understand the changing dynamics of today’s
workplaces and the landscape of the economy. This is what puts us one
step ahead when it comes to selecting the right fit for your
organization.
The Staff Software Quality Engineer is responsible for
leading teams through the product and business software quality
system. The incumbent will have insight into process implementation
and advises the project team on how to optimally execute software
processes and standards to meet the needs of the
project.
•Working with software project teams to ensure
regulations and compliance to ensure successful submissions and
audits
•Lead software project teams to achieve the most efficient
compliant process for product software development to reduce project
costs.
•Continually provides feedback to refine the software
development process to maximize effectiveness.
The individual
will act as the leading representative of the Diabetes Care Team.
Support medical device and mobile/desktop application software for new
product development projects. Serve as Quality Assurance
representative on project teams related to the development of non-
product software applications. Interface with supplier and customer
Quality Assurance personnel on software development projects to
coordinate regulatory and development processes. •Participate on
Software Review and Milestone committees and NPD Technical Review
boards as requested. Prepare supplier software evaluation reports, gap
analyses, and risk management plans to ensure software suppliers plan
and deliver appropriate software and documentation.
Bachelor's degree in
Computer Science, Software Engineering, Computer Engineering, or
related field.
Minimum 5 years of experience of technical software
experience, which includes design, coding, testing.
Experience in
contributing to process improvement and expert-level knowledge of your
current organization’s established software processes.
Possess
excellent interpersonal skills and able to work effectively with a
diverse group of people and senior executives.
Deep level of
understanding and experience within medical device software
development including, but not limited to FDA PMA and 510k
submissions, EU IVD , and Technical Files.
Excellent communication
and writing skills.
Strong negotiation skills
Able to
effectively produce change.
Highly Preferred
Qualifications:
•CSQE
•Experience developing systems that
consist of medical devices which wirelessly communicate with mobile
(iOS, Android) or cloud-based applications.
•Experience with
SharePoint, DOORS, MKS.