Lead Quality Assurance Engineer

3 weeks ago


Hudson, United States BioTalent Full time

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

  • Manage QMS in accordance to ISO 13485.
  • 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.


Qualifications


  • 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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