Software Quality Assurance Engineer m/f
- Company compliance expert to ensure computerized system and software used as a medical device, used in medical device application, or used in regulated environment complies with industry practices and comply with internal requirements, applicable external standards and regulations.
- Provide expertise in applicable industry standards and regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO13485, ISO14971, IEC 62366-1.
- Review, support, and improve all phases of the Software Development Life Cycle (SDLC) documentation (e.g. requirements, architecture, verification, validation, test, etc.).
- Provide guidance and expertise on all software development procedures and practices.
- Actively participate as QA representative in software team meetings (e.g. code review, risk analysis, etc.).
- Actively participate in Risk Analysis discussions with the product development team(s).
- Provide independent review to the software development and test team(s).
- Provide guidance in the development of specific tests and testing methodologies to the software test team.
- Provide cross functional support to other Quality Department functions, including other sites within PerkinElmer Medical Imaging
Job Requirements :
- University degree Computer Science or equivalent experience required
- Five or more years' experience working as a software QA Engineer in a medical device regulated organization required
- Direct work experience with medical device software related standards and regulations such as IEC 62304, FDA guidance, FDA Part 11, ISO13485, ISO14971, IEC 62366-1 required
- In-depth knowledge on Software Quality Assurance Engineering fundamentals required
- Experience in designing software testing strategies required
- Working knowledge of C++/C/C# programming languages required
- Knowledge of additional programming languages is preferred
- Experience with defect, test and configuration management tools (e.g., JIRA, DOORS, Polarion, Microsoft TFS, etc.).
- Strong time management skills and ability to prioritize
- Requires flexible work schedule and support of international company business time zones, and locations
- Working knowledge of Quality System Requirements to meet ISO 13485, MDD, and FDA QSR required
- Experienced in handling external audits preferred
- Experience with FDA inspections is desired.
- Qualified internal auditor for ISO 13485 and or FDA QSR desired
- Fluent in German and English (written and spoken)
% of Travel Required : None
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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