Manager - Quality Assurance

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Quality Assurance Manager. This role will support our continued growth in our second manufacturing building.  Successful candidate must possess a Bachelor’s degree in an Engineering or Engineering Technology discipline and a minimum of three years of supervisory/management experience in a manufacturing environment. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

To oversee, manage and provide direction to the Quality department that will effectively and profitably meet or exceed the internal and /or external client’s expectations by providing superior quality products and service.

Essential Duties and Responsibilities:

• Manages a team of Quality Supervisors, Quality Engineers, Quality Technicians Quality Inspectors, responsible for all areas of Quality support for one or more manufacturing areas. Focus on providing timely and efficient flow of products, services, and projects.
• Collaborates cross-functionally across the organization to ensure the Quality organization is properly aligned with organizational goals and direction. Promotes Quality excellence to business partners and supports efforts to maintain and improve predictable product flow.

Process Management

• Drive quality improvement/defect reduction and process efficiencies by applying appropriate statistical tools / methodologies.
• Partner with key stakeholders to reduce errors/defects and/or improve efficiencies on QMS processes
• Responsible for maintaining and equipping the inspection department to meet the needs of tests and inspections required by new and modified products. Ensures inspection activities are completed in a timely manner to support product flow, including receiving, in-process, and final product inspection, testing and release.
• Management of NCR, MRB, deviation and CAPA execution, ensuring timely and appropriate disposition of materials; Ensures investigations use robust problem-solving techniques, and corrective action plans are commensurate with risk.
• Establishes, monitors and reports Key Performance Indicators (KPI) for department and site. Properly escalates negative trends or results for follow up action. Links process performance data back to risk management files through PFMEA.  
• Responsible for ensuring the integrity and completeness of Device History Records and other Quality records.
• Supports internal and external auditing activities, serving as an SME for the Quality organization.

People Management

• Responsible for organizational development, hiring and disciplinary action for the Quality department.
• In conjunction with Training partners, responsible for defining organizational training requirements and ensuring all members of the Quality organization are properly trained. Enhance team member competencies in the areas of Quality Engineering and Quality Control.
• Actively coaches and provides feedback to team members to address performance issues. Establishes promotional ladders for key roles. Develops future leaders by effective selection, mentoring, and developmental activities. Addresses performance issues promptly and develops key talent and succession plans.
• Communicates with team, peers, and leadership on the status of the department and its ability to service internal and external customers.

Education and Experience:

• Bachelor’s Degree in an Engineering or Engineering Technology discipline required
• 10 years of Medical Device Manufacturing experience preferred
• 3 years of supervisory / management experience

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Knowledge of testing equipment and applicable national standards relating to testing (i.e. ASTM standards, etc).  Familiarity in operating all test and inspection equipment used in Quality.  Familiarity with applicable federal, military, FDA, ISO and EN specifications.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.