Quality Systems Engineer — Regulatory Validation (Hybrid)

Apple Inc.; Cupertino, Northern (CA, KY); Hybrid; 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

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.