QMS Engineering Manager - Medical Devices
About The Position
The QMS Engineering Manager will be responsible for overseeing a team of engineers responsible for the validation of all non-product software used in the design and production of medical devices. Beyond maintaining a compliant state, this leader is responsible for optimization by implementing automation and AI. This team manages the tools and systems that build the product. This person will oversee a team of validation engineers responsible for the optimization of the quality management system (including non product software) and managing the lifecycle of the software systems. This includes the following activities: • Non product software validations • QMS Process Optimization • Integration of AI in the quality management system
Requirements
- Bachelor’s Degree or equivalent experience
- 10+ years of experience in Quality Management Systems supporting Medical Devices
- Six Sigma Green/Black Belt
- Knowledge of medical device regulatory requirements (e.g. ISO13485, MDSAP requirements, China GMP, EU MDR etc…)
- Strong project management skills—ability to lead cross-functional teams without direct authority
- Ability to influence stakeholders to adopt modern techniques
- Experience with AI/ML
- Experience with eQMS software
Nice To Haves
- Excellent written and verbal communication skills
- Experience presenting to executive management
- Excellent interpersonal skills working across multiple divisions
- Attention to detail, well organized and time efficient
- Can multi-task and work independently
- Experience with software as a medical device
- PMP Certification
Responsibilities
- Non product software validations
- QMS Process Optimization
- Integration of AI in the quality management system
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
