Director Of Quality Assurance
Billerica, Massachusetts, Us
Quality Director and management representative responsible for the following:- Quality Management System development, continuous improvement and compliance to 21 CFR 820.- Quality System governance of document control, training, CAPA, NCR, complaint, Medical Device Reporting (MDR), field corrective action, internal audit, supplier quality, management review, inspection readiness and calibration. - New product development support and compliance to 21 CFR 820.30 Design Control activities.- Quality Engineering and Quality Control supporting manufacturing.- Leadership, mentoring and coaching to direct reports and staff.