- Manage QMS in accordance to ISO
- Oversee training and development of junior staff; ex: technicians and inspectors.
- Oversee daily quality initiates, including calibration, CAPAs, continuous improvement, gages, and complaint handling.
- Report into the VP of Quality for all quality KPIs and metrics.
- Establish, control, and interpret capability studies and FMEA's in concert with other disciplines.
- Participate in internal and external quality audits.
- Review customer quality issues with Sales and Customer Service.
- Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
- 5+ years' of industry experience
- ISO 13485 experience is required.
- Strong experience with daily quality initiatives - candidates will be tested during the interview process to ensure they have the required level of understanding.
- Plastics experience is preferred.
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Lead Quality Assurance Engineer - Hudson, United States - BioTalent
Description
We are partnered with a premier medical-device contract manufacturer out of Hudson, New Hampshire to hire a Lead Quality Engineer. This individual will be leading daily quality initiatives as well as overseeing technicians on the shop floor.
Responsibilities
Qualifications