Job Description:
Responsible for leading the Quality group, including a team of Quality Engineers and QC Techs. Work closely with the Operations team to support production management and initiatives and maintain compliance with company QMS.
Job Responsibilities:
- Lead the manufacturing Quality group
- Own the Quality System in handling NCRs, CAPAs, customer complaints, and change controls
- Medical Device Reporting (MDR) to the FDA
- Oversee equipment control and calibration programs
- Identify and Lead continuous improvement activities to enhance Quality Systems
Job Qualifications:
- BS in technical field (preference for Engineering)
- 10+ years in Quality and Medical Device industry
- At least 2 years in a management role
- Working knowledge of 21 CFR 820 and ISO 13485
- Ability to review and write technical documentation
