Quality Assurance Manager
- 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 company’s corrective action system.
- Lead MRB activity.
- Perform process audits on the manufacturing floor.
- Plan, manage, and drive the internal audit program within the plant.
- Bachelor’s 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.
Paid Vacation, Holidays. 401K Match, Healthcare benefits