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Varex Imaging in Salt Lake City, UT is seeking a Software QA Engineer as a 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. In addition to:
Responsibilities & Requirements:
- 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
Minimum Required Skills and Knowledge:
- Bachelor degree in Engineering or equivalent experience required
- Five or more years experience working as a Software QA Engineer
- Requires flexible work schedule and support of international company business time zones, and locations
Preferred Skills and Knowledge:
- In-depth knowledge on Software Quality Assurance Engineering fundamentals
- Five or more years experience working as a software QA Engineer in a medical device regulated organization
- 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
- Experience in designing software testing strategies
- Working knowledge of C++/C/C# programming languages
- Knowledge of additional programming languages is preferred
- Experience with defect tools (e.g., JIRA, Polarion, Microsoft TFS, etc.)
- Strong time management skills and ability to prioritize
- Working knowledge of Quality System Requirements to meet ISO 13485, MDD, and FDA QSR
- Experience with FDA inspections .
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We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Pay Rate Type:
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.