Software Quality Assurance Engineer m/f - Germany
- 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 company 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)