Job Details

Quality Systems Engineer - Infrastructure

Cupertino, California, United States

Hardware

Summary

Posted: Jun 14, 2025

Weekly Hours: 40

Role Number: 200557275

Apple Health’s ever-evolving suite of health and wellness products 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 approach to health - strengthening our commitment to leave the world better than we found it.

If 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 hands.

Description

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

Minimum Qualifications

• 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

Preferred Qualifications

• 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.

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 $112,900 and $188,100, 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. (https://www.apple.com/careers/us/benefits.html)

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 (https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .

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 (https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .

Apple will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation.

Apple participates in the E-Verify program in certain locations as required by law.Learn more about the E-Verify program (https://www.apple.com/jobs/pdf/EverifyPosterEnglish.pdf) .

Apple is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. Reasonable Accommodation and Drug Free Workplace policy Learn more .

Apple is a drug-free workplace. Reasonable Accommodation and Drug Free Workplace policy Learn more .

Apple will consider for employment all qualified applicants with criminal histories in a manner consistent with applicable law. If you’re applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.