Quality Systems Engineer - Health

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. Conduct risk assessments and define validation scope and testing strategies. Perform software testing (functional, regression, and user acceptance) as part of validation activities. Document test results, deviations, and nonconformances, and work with stakeholders to resolve issues. Ensure traceability of requirements through validation documentation. Maintain validation documentation to support audits and inspections. Work with cross-functional team members to model Quality processes in quality management software systems. Complete and support end-to-end verification of automated Quality processes to ensure compliance with applicable standards. Ensure that systems conform to data protection schemes for handling of sensitive data. Implement and maintain system integrations between regulated and enterprise non-product software systems. 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.

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