Quality Systems Engineer Health

The Health group is seeking a meticulous and experiencedQuality Systems Engineerto join our 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 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 join our team!n

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.n

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

B.S. ME/EE/BME/CS degree or equivalent in any engineering/science disciplinen3 years of medical device experience in a quality/regulatory rolenFamiliarity with 21 CFR Part 11 21 CFR 820 ISO13485 ISO 14971 IEC 62366 IEC 62304 and other applicable regulationsnExperience working on software products within a quality or regulatory systemnExperience interpreting requirements and following standard operating proceduresnExperience with electronic Quality Management Systems including Post Market Surveillance / Complaint HandlingnExceptional organizational and leadership skillsnAbility to be onsite weekly; this role is a hybrid in-person

Expertise in execution of design controlsnProven background in being autonomous and being able to clearly work towards establishing goals and initiatives with minimal oversightnDemonstrated competence in determining appropriate global regulatory requirements for new products or product changesnExcellent communication skills both verbal and written