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Description
The Quality Systems Engineer will develop and execute regulated non-product software systems validation in accordance with applicable regulatory standards (e.g., FDA 21 CFR Part 11, ISO 13485), while collaborating with cross-functional teams including developers, vendors, QA, regulatory affairs, and system users to define validation requirements and acceptance criteria. This person will analyze business and system requirement specifications to ensure testability and compliance with intended use.
Minimum Qualifications
B.S. ME/EE/BME/CS degree or equivalent in any engineering/science discipline 3+ years of medical device experience in a quality/regulatory role Familiarity with 21 CFR Part 11, 21 CFR 820, ISO13485, ISO 14971, IEC 62366, IEC 62304 and other applicable regulations Experience working on software products within a quality or regulatory system Experience interpreting requirements and following standard operating procedures Experience with electronic Quality Management Systems including Post Market Surveillance / Complaint Handling Exceptional organizational and leadership skills Ability to be onsite weekly; this role is a hybrid, in-person position.
Preferred Qualifications
Expertise in execution of design controls Proven background in being autonomous and being able to clearly work towards establishing goals and initiatives with minimal oversight Demonstrated competence in determining appropriate global regulatory requirements for new products or product changes Excellent communication skills, both verbal and written
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