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Apple Quality Systems Engineer - Infrastructure United States, California, Cupertino 804834054
Today
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 multi-functional teams and regulatory standards. This includes both custom-developed and third-party software used in product development, manufacturing, and business operations. Responsiblities include:• Develop and execute regulated non-product software systems validation in accordance with applicable regulatory standards (e.g., FDA 21 CFR Part 11, ISO 13485).• Collaborate with multi-functional teams including developers, QA, regulatory affairs, and system users to define validation requirements and acceptance criteria.• Analyze system requirements and 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 non-conformances, and work with partners 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 system• Completing and supporting end to end verification of automated Design Control deliverable generation to ensure compliance with applicable standards• Ensuring that Design Controls are properly implemented in accordance to established standard operating procedures and produce a compliant deliverable• Implement and maintain system integrations between regulated and enterprise non-product software systems
- Bachelor's degree: BSME/EE/BME/CS degree or equivalent in any engineering/science field.
- 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 interpreting requirements and following standard operating procedures
- Experience with design control, and risk management activities for medical devices, including development and maintenance of design history files
- Expertise in execution of design controls.
- Exceptional organizational and management skills
- Excellent interpersonal skills, both verbal and written
- Experience working on software products within a quality or regulatory system.
- Proven background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal guidance.
- Demonstrated competence in determination of appropriate global regulatory requirements for new products or product changes.
- Strong organizational and leadership skills.
- Excellent communication skills, both verbal and written.
Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.
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