Orthopedic Medical Device experience strongly preferred
The Quality Assurance Manager will work cross-functionally with Engineering, Product Management, and Inventory, plus global acquisitions and joint ventures in a hands-on role that embraces teamwork, change, risk-based decision making and ?exibility. This individual is responsible for the Quality Management System (QMS). The position works with a multi-discipline team, must be self- motivated and must have excellent written and verbal communication skills. This individual must promote a company-wide culture of quality and ensure collaboration with other departments to ensure the achievement of company objectives.
Responsibilities • Serves as Management Representative • Supports creation of and updates to post market surveillance activities. • Supports the organization with acquisitions and joint ventures to ensure that the Quality Systems are consistent with the organizational needs and compliant to global regulatory requirements. • Accountable for all Quality functions - creates and updates operating and quality procedures. This includes: customer feedback and complaints, corrective and preventive actions, control of nonconforming materials, supplier quality, internal audit, design controls, and document and records control. • Manage Quality sta? responsible for new product development quality, supplier quality, including nonconforming materials, and monitoring and measuring the Quality Management System. • Provides coaching, guidance, and training to sta?, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high-quality sta?. • Acts as leader of Management Review by coordinating the collection of data and hosting the presentation of data and information for the management team to ensure the QMS is suitable, adequate, and effective. • Supports new product development. • Accountable for monitoring and analyzing trends in process and product performance, including supplier performance. • Provide leadership in all areas of the Quality System. • Coordinate quality activities with other company departments. • Communicate e?ectively at all levels within Quality as well as cross functionally with departments such as Engineering, Product Management, and Purchasing. • Other duties as assigned
Preferred Quali?cations • Bachelor's Degree in Engineering or related technical or scienti?c discipline preferred • 6 years' experience in quality in an FDA-regulated industry with recent Orthopedic medical device experience. • Experience leading a team of professionals by providing coaching, leadership, and direction. • Excellent problem solving, decision-making, and root cause analysis skills are required. • FDA QSR, 21CFR820, including establishment registration and listings, and new product submissions. • ISO 13485:2016 and EN ISO 13485:2016 • MDD 93/42/EEC directive, including CE Mark applications and Technical Files. • EU MDR 2017/745 • Risk Management, ISO 14971:2019 • MDSAP • CMDR (Canada), SOR/98-282, including licenses. • Brazilian Health Surveillance Agency (ANVISA) Resolution RDC no. 2, including approvals and registrations. • Australia TG(MD)R • Japan MHLW MO169