Manager, Equipment Quality & Controls
TransMedics(21 days ago)
About this role
The Manager, Equipment Quality & Controls is responsible for developing and leading a global, compliant equipment controls program across manufacturing sites, focusing on digital transformation, process standardization, and quality enhancement. The role involves strategic planning, process design, system integration, cross-site implementation, and team leadership within a regulated medical device or biotech environment.
Required Skills
- MES
- Digital Workflows
- Regulatory Compliance
- Process Improvement
- Equipment Qualification
- Calibration
- Project Management
- ISO 13485
- Quality Systems
- GMP
Qualifications
- Bachelor’s degree in Engineering, Quality, or related field
- 7+ years experience in regulated medical device, pharmaceutical or biotech manufacturing
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