Production Quality Manager - Health

Summary Posted: Jul 1, 2024 Weekly Hours: 40 Role Number: 200556079 Our ever-evolving suite of Heath and Wellness products for iPhone and Watch are helping our users live more active, healthier lives. Be ready to make something great when you come here. Our ever-evolving suite of Heath and Wellness products for iPhone and Watch are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our business practices - strengthening our commitment to leave the world better than we found it. The Health Special Projects group is looking for a Production Quality Manager to oversee quality engineering activities, and support Quality management system efforts for its medical device products. Description Description You will lead a team of quality engineers to ensure that products meet quality goals, and regulatory requirements including but not limited to FDA Quality System Regulations, ISO 13485, EU MDR requirements, and risk management per ISO 14971. You will handle defining and implementing standard operating procedures to meet regulatory requirements while leading risk management activities in relation to design and production changes, and issues discovered during testing, and in the field. You will also focus on: • Partnering with the post-market surveillance team and external partners to drive improvements for sustaining products • Ensuring the execution of systems which identify and resolving quality issues (CAPAs) • Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Ensuring the investigation, resolution and prevention of product and process non-conformance • Providing support for other quality activities and initiatives, quality data collection and trending, internal and external audits, training, authoring procedures, etc. • Identifying quality improvement initiatives in support of QMS and other regulatory requirements. • Supporting initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements. The Quality Manager needs to be able to prioritize issues and track the details, as well as be in touch with the big picture issues. We are looking for someone who is flexible and can respond quickly and enthusiastically to changes. Additionally, cross-functional communication skills and experience are crucial to success in this role. You will interact with all engineering design disciplines and project management teams, and will be responsible for handling communications, preserving project schedules, crafting meetings with detailed action items and progress and reporting and presenting to cross functional teams. Minimum Qualifications Minimum Qualifications B.S. ME/EE/BME/CS degree 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 Experience with design control, production& process control, and risk management activities for medical devices, including development and maintenance of design history files Expertise in execution of design controls and production processes. Key Qualifications Key Qualifications Preferred Qualifications Preferred Qualifications Experience working on software and hardware products within a quality or regulatory system. Shown background in being autonomous and being able to clearly work towards establish 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. Education & Experience Education & Experience Additional Requirements Additional Requirements Pay & Benefits Pay & Benefits 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 $143,100 and $238,500, 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. Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program. More 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.