Sr Quality Technician
About The Position
The Sr Quality Technician applies advanced knowledge of quality procedures and equipment in a regulated medical device manufacturing environment. The role resolves most issues independently, prioritizes work, supports training, and leads by example by formally training junior staff or serving as a resource to less experienced colleagues. The position applies relevant FDA regulations, ISO 13485, GMP principles, and quality assurance practices; supports product testing, inspection, statistical quality control, risk management, post-market surveillance, design controls, and audits; and leads CAPA investigations and sustainable corrective actions.
Requirements
- 3–5+ years of experience in the medical device industry, including at least 3 years in Quality Engineering or Quality Systems.
- Proven experience with nonconformance management, CAPA, root cause analysis, and product quality.
- Experience working within a regulated manufacturing environment.
- Strong working knowledge of medical device quality and regulatory requirements, including FDA Quality System requirements, ISO 13485, EU Medical Device Regulation (EU MDR), and Good Manufacturing Practices (GMP).
- Understanding of quality system requirements and industry best practices.
- Experience managing and investigating nonconformances.
- Experience leading CAPA activities and root cause investigations.
- Experience with process validation and manufacturing process controls.
- Experience with change control and change management.
- Experience with software validation, as applicable.
- Ability to analyze quality data, identify trends, and drive corrective and preventive actions.
- Experience partnering with Manufacturing, Engineering, Operations, and other cross-functional teams to resolve quality issues.
Nice To Haves
- Bachelor’s degree in Engineering, Quality, Biomedical Engineering, or a related technical field preferred; experience may be accepted in lieu of a degree.
Responsibilities
- Apply advanced understanding of quality procedures and equipment.
- Resolve most issues independently.
- Prioritize tasks and support training.
- Lead by example, formally train junior staff, and act as a resource for colleagues with less experience.
- Apply FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards.
- Use GMP principles and quality assurance practices.
- Perform or support product testing, inspection, and statistical quality control.
- Apply risk management methodologies and post-market surveillance practices.
- Lead CAPA investigations and implement sustainable corrective actions.
- Participate in internal and external audits.
- Manage and investigate nonconformances and lead root cause investigations.
- Support process validation and manufacturing process controls, change control and management, and software validation as applicable.
- Analyze quality data, identify trends, and drive corrective and preventive actions.
- Partner with Manufacturing, Engineering, Operations, and other cross-functional teams to resolve quality issues.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
