Quality Assurance Manager (On-site)

The following is intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. Job Purpose This position works 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 flexibility. 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. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Duties and Responsibilities Duties include one or more of the following: Serves as Management Representative (MR). 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 staff responsible for new product development quality, supplier quality, including nonconforming materials, and monitoring and measuring the Quality Management System at TriMed. Provides coaching, guidance, and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high-quality staff. 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 effectively at all levels within Quality as well as cross functionally with departments such as Engineering, Product Management, and Purchasing. Other duties as assigned Qualifications Working knowledge of the following: 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 Bachelor's Degree in Engineering or related technical or scientific discipline preferred 6 years’ experience in quality in an FDA-regulated industry. Experience leading a team of professionals by providing coaching, leadership, and direction. Excellent problem solving, decision-making, and root cause analysis skills are required. Working Conditions This position works in an open office environment. While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk and sit. The position may require up to 20% travel. Physical Requirements Works in an office environment sitting for long periods of time. The employee may occasionally lift and/or move up to 25 pounds.