Production Quality Engineer - Medical Devices
Cellular Vehicles
Quality Assurance
Cupertino, CA, USA
Posted on Mar 14, 2026
Summary
Apple is where individual imaginations gather together, committing to the values that lead to great work. Every new product we build, service we create, or Apple Store experience we deliver is the result of us making each other’s ideas stronger. That happens because every one of us shares a belief that we can make something wonderful and share it with the world, changing lives for the better. It’s the diversity of our people and their thinking that inspires the innovation that runs through everything we do. When we bring everybody in, we can do the best work of our lives. Here, you’ll do more than join something — you’ll add something.
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 Engineer to oversee Quality engineering activities, and support quality management system efforts for its medical device products. We’re looking for innovative thinkers and doers who are passionate to make a real impact in people’s lives.
Description
We are looking for a cross-functional Quality team member, working closely with Engineering, Project management, and Post-Market surveillance teams. This role is critical in driving product and process issue resolution, implementing Quality improvements, performing risk assessments, and ensuring clear communication and timely progress reporting across teams. This person will 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, while defining and implementing standard operating procedures (SOPs).
This is a site-based role.
Responsibilities
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 $146,300 and $244,100, 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.
Apple is an equal opportunity employer that is committed to inclusion and diversity. We seek to promote 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.
Apple accepts applications to this posting on an ongoing basis.
Apple is where individual imaginations gather together, committing to the values that lead to great work. Every new product we build, service we create, or Apple Store experience we deliver is the result of us making each other’s ideas stronger. That happens because every one of us shares a belief that we can make something wonderful and share it with the world, changing lives for the better. It’s the diversity of our people and their thinking that inspires the innovation that runs through everything we do. When we bring everybody in, we can do the best work of our lives. Here, you’ll do more than join something — you’ll add something.
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 Engineer to oversee Quality engineering activities, and support quality management system efforts for its medical device products. We’re looking for innovative thinkers and doers who are passionate to make a real impact in people’s lives.
Description
We are looking for a cross-functional Quality team member, working closely with Engineering, Project management, and Post-Market surveillance teams. This role is critical in driving product and process issue resolution, implementing Quality improvements, performing risk assessments, and ensuring clear communication and timely progress reporting across teams. This person will 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, while defining and implementing standard operating procedures (SOPs).
This is a site-based role.
Responsibilities
- Leading Risk Management activities in relation to design changes, and issues discovered during internal testing, and in the field.
- Coordinates with local sites (e.g. China) on design changes and manufacturing release of products
- Partner with the Post-Market surveillance team to drive improvements for sustaining products and to establish a risk management process throughout a product’s lifecycle.
- Leading the execution of systems which identify and resolve Quality issues (CAPAs).
- Working with the teams on investigation, resolution and prevention of product and process non-conformances (NC)
- Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving Quality issues.
- Leading and implementing various product and process improvement methodologies in identifying, prioritizing, communicating, and resolving Quality issues.
- Identify 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.
- Complying with applicable regulatory requirements, procedures, and processes, requirements
- Provide support for other Quality activities and initiatives, quality data collection and trending, internal and external audits, training, authoring procedures, etc.
- The candidate 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 social skills and experience are essential to success in this role. This person will interact with all engineering design disciplines and project management teams. You will be responsible for managing communications, preserving project schedules, crafting meetings with detailed action items and progress and reporting and presenting to cross functional teams.
- B.S. ME/EE/BME/CS degree or equivalent in any Engineering/Science discipline
- 5+ 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 following standard operating procedures
- Experience with design control and risk management activities for Medical devices, including development and maintenance of design history files
- Experience working on software and hardware products within a Quality or regulatory system.
- Expertise in execution of design controls.
- Proven background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight.
- 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.
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 $146,300 and $244,100, 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.
Apple is an equal opportunity employer that is committed to inclusion and diversity. We seek to promote 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.
Apple accepts applications to this posting on an ongoing basis.