Job Description

The  Health group is seeking a meticulous and experienced Quality Systems Engineer to join our team. In this role, you will be responsible for planning, executing, and documenting the validation of software systems to ensure they meet specified requirements for cross-functional teams and regulatory standards. This includes both custom-developed and third-party software used in product development, manufacturing, and business operations.

If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient team who works closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into our customers’ hands.

Come join our team!

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.

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

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.