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Production Quality Manager
2 months ago
Join Apple's Health Special Projects group as a Production Quality Manager, where you will oversee quality engineering activities and support Quality Management System efforts for medical device products.
Key Responsibilities:- Lead a team of quality engineers to ensure products meet quality goals and regulatory requirements, including FDA Quality System Regulations, ISO 13485, and EU MDR requirements.
- Define and implement standard operating procedures to meet regulatory requirements and lead risk management activities related to design and production changes, and issues discovered during testing and in the field.
- Partner with the post-market surveillance team and external partners to drive improvements for sustaining products.
- Ensure the execution of systems that identify and resolve quality issues (CAPAs).
- Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
- Ensure the investigation, resolution, and prevention of product and process non-conformance.
- Provide support for other quality activities and initiatives, quality data collection and trending, internal and external audits, training, authoring procedures, etc.
- Identify quality improvement initiatives in support of QMS and other regulatory requirements.
- B.S. in ME/EE/BME/CS or equivalent in any engineering/science discipline.
- 10+ years of medical device experience in a quality/regulatory role.
- Familiarity with 21 CFR 820, ISO13485, ISO 14971, IEC 62366, IEC 62304, and other applicable regulations.
- Experience interpreting requirements and implementing standard operating procedures.
- Expertise in execution of design controls and production processes.
- Experience working on software and hardware products within a quality or regulatory system.
- Shown background in being autonomous and clearly working towards established goals and initiatives with minimal oversight.
- Proven competence in determination of appropriate global regulatory requirements for new products and product changes.
- Strong organizational and leadership skills.
- Excellent communication skills, both verbal and written.
At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $146,000 and $243,300, and your base pay will depend on your skills, qualifications, experience, and location.
Apple employees also have the opportunity to become an Apple shareholder through participation in Apple's discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple's Employee Stock Purchase Plan. You'll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses — including tuition.
Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. Learn more about Apple Benefits.
Apple is an equal opportunity employer that is committed to inclusion and diversity. We take affirmative action to ensure equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics. Learn more about your EEO rights as an applicant.
