JobsQMS Engineering Manager - Medical Devices
Job description
The QMS Engineering Manager will lead a team of engineers focused on validating non-product software used in the design and production of medical devices. This role is critical in ensuring compliance with medical device regulatory requirements while also driving optimization through automation and AI integration. The team collaborates closely with multiple functional teams to deliver innovative health and wellness products. A passion for the health space and a commitment to quality management are essential for success in this position.
Requirements
- Bachelor's Degree or equivalent experience
- 10+ years of experience in Quality Management Systems supporting Medical Devices
- Six Sigma Green/Black Belt certification
- Knowledge of medical device regulatory requirements such as ISO13485 and EU MDR
- Strong project management skills with the ability to lead cross-functional teams
- Experience with AI/ML technologies
- Experience with eQMS software
- PMP Certification
Responsibilities
- Oversee a team of validation engineers responsible for optimizing the quality management system.
- Manage the lifecycle of software systems related to medical devices.
- Conduct non-product software validations to ensure compliance.
- Implement QMS process optimization strategies.
- Integrate AI into the quality management system.
Benefits
- Employees at Apple are often offered comprehensive benefits that support physical and mental well-being—flexible medical plans, confidential counseling, onsite wellness centers at major campuses, and resources for fitness and daily life. Families typically receive fertility support, paid parental leave with gradual return, caregiving leave, and dependent-care guidance, while financial perks commonly include stock grants (with purchase discounts), 401(k) matching, and income-protection coverage. Employees also see robust time off, Apple University learning and tuition reimbursement, donation matching and paid volunteer hours, and deep product and partner discounts.
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