Quality Assurance Manager

Kamis Professional Staffing Hartford , CT 06123

Posted 3 days ago

  • Manage the Quality Management System including assuming effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, internal auditing, and manufacturing support.
  • Improve quality assurance systems plant-wide to achieve zero defects.
  • Maintain and enhance plant level quality system performance metrics.
  • Ensure site-wide training is effective and that the plant operates within the required regulatory guidelines examining and testing plant-wide processes and products from a final product acceptance and compliance perspective.
  • Responsible for the continued development GMP capability and maintenance of compliance to US FDA Quality System Regulation (QSR, Part 820). Coordinate ISO13485 upgrade training, certification and maintenance.
  • Ensure effective transfers of new products into production that meet all Quality requirements for the classification.
  • Effectively work with Engineering Managers and Advanced Quality Engineers to ensure Production Part Approval Process (PPAP) validation.
  • Improve profitability through reduced internal scrap and customer returns.
  • Mentor, train, and closely work with plant based Quality Engineers, inspectors, and technicians to foster team work and communicate departmental priorities
  • Lead root cause investigation and champion the companys corrective action system.
  • Lead MRB activity.
  • Perform process audits on the manufacturing floor.
  • Plan, manage, and drive the internal audit program within the plant.
  • Other tasks as necessary

Requirements

  • Bachelors Degree in Engineering or equivalent
  • Minimum of 8+ years quality assurance or quality engineering with supervisory experience in an FDA-registered facility for medical device manufacturing.
  • FDA audit experience
  • Knowledge of the Medical Device GMP regulations and their appropriate application
  • Certified Quality Engineer, Certified Lead Auditor, and Six-Sigma black belt preferred
  • Excellent negotiation, presentation, meeting facilitation, and organizational skills.
  • Strong customer relationship building skills.
  • Strong hands on analytical problem solving abilities.
  • Excellent written and oral communication skills.

Benefits

401k, health/dental, vision and paid time off.

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