Quality Systems Engineer - Health

Apple Inc.; Cupertino, Northern (CA, KY); On-site; USD 121,000 - 201,000; Full time

Benefits offered by this job

Medical and dental coverage

Retirement benefits

Employee stock programs

Job summary

Apple Inc. in Cupertino, California, is seeking a meticulous Quality Systems Engineer to lead the validation of software systems used in product development, manufacturing, and business operations.

You will collaborate with cross-functional teams to define validation requirements, execute testing strategies, document results, and ensure compliance with FDA 21 CFR Part 11, ISO 13485, ISO 14971, IEC 62366, and IEC 62304.

Qualifications

• BS in engineering or sciences; 3+ years in medical device quality/regulatory roles.
• Familiarity with 21 CFR Part 11, 820, ISO13485, ISO14971, IEC 62366/62304.
• Experience with software products within quality/regulatory systems.
• Ability to interpret requirements and follow SOPs; strong documentation skills.

Responsibilities

• 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 nonconformances; coordinate with stakeholders to resolve issues.
• Ensure requirements traceability through validation documentation.
• Maintain validation documentation for audits and inspections.
• Model Quality processes in quality management software systems with cross-functional teams.
• Complete end-to-end verification of automated Quality processes to ensure regulatory compliance.
• Ensure data protection for handling of sensitive data.
• Implement and maintain system integrations between regulated and non-product software.

Skills

Quality systems

Regulatory compliance

Software validation

Risk assessment

Documentation & traceability

Cross-functional collaboration

Communication skills

Onsite weekly/hybrid

Education

Bachelor's degree in engineering or sciences

Tools

Quality management software

Job description

Cupertino, California, United States Software and Services

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 cross-functional teams and regulatory standards. This includes both custom-developed and third-party software used in product development, manufacturing, and business operations. 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. Come join our team!

Description

The Quality Systems Engineer will develop and execute regulated non-product software systems validation in accordance with applicable regulatory standards (e.g., FDA 21 CFR Part 11, ISO 13485), while collaborating with cross-functional teams including developers, vendors, QA, regulatory affairs, and system users to define validation requirements and acceptance criteria. This person will analyze business and system requirement specifications to ensure testability and compliance with intended use.

Responsibilities

• 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 nonconformances, and work with stakeholders 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 systems.
• Complete and support end-to-end verification of automated Quality processes to ensure compliance with applicable standards.
• Ensure that systems conform to data protection schemes for handling of sensitive data.
• Implement and maintain system integrations between regulated and enterprise non-product software systems.

Minimum Qualifications

• B.S. ME/EE/BME/CS degree or equivalent in any engineering/science discipline
• 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 working on software products within a quality or regulatory system
• Experience interpreting requirements and following standard operating procedures
• Experience with electronic Quality Management Systems including Post Market Surveillance / Complaint Handling
• Exceptional organizational and leadership skills
• Ability to be onsite weekly; this role is a hybrid, in-person position.

Preferred Qualifications

• Expertise in execution of design controls
• Proven background in being autonomous and being able to clearly work towards establishing goals and initiatives with minimal oversight
• Demonstrated competence in determining appropriate global regulatory requirements for new products or product changes
• 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 $120,900 and $201,400, 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

At Apple, we believe accessibility is a fundamental human right. You’ll find that idea reflected in everything here — in our culture, our benefits and our digital tools. By welcoming as many perspectives as possible, we help you build a career where you feel like you belong.

Learn about accessibility in Apple’s workplace

Learn about reasonable accommodations for job applicants

Apple accepts applications to this posting on an ongoing basis.