Quality Assurance Manager
Arthrex Manufacturing Inc
ALC-AMI- Fort Myers, FL
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 and directs the efforts of the Quality Control Inspectors and Quality Control Supervisors. Supervises Quality Engineers and Quality Assurance Technicians assigned to manufacturing departments work activities to provide timely and efficient flow of services and projects. Maintains a leading edge understanding of the quality processes required in manufacturing orthopedic devices and components in order to find new and novel opportunities to improve quality and reduce cost. Evaluates and develops improved quality techniques for the control of product activities. Timely dispositions Material Review Board and Corrective Action issues Reviews, approves and coordinates intradepartmental approval of internal and externally generated deviations, maintain log of same. Reports progress and status of projects on a timely basis with emphasis on reporting results to the Director, Quality Assurance and Manufacturing Engineering Manager. Responsible for interfacing with Vendors regarding discrepant incoming articles and coordinating MRB efforts Responsible for assuring the integrity and completeness of Device History Files Responsible for staffing, positioning, hiring and disciplinary action (as necessary) the Quality department Responsible for maintaining and equipping the inspection department to meet the needs of tests and inspections required by new and modified products Responsible for assuring First Article Inspections are completed by Vendors for all new/modified articles Responsible for assuring QC Inspectors are properly trained in all inspection equipment and techniques, procedures and SOPs Responsible for maintaining efficient work flow, work assignments and throughput standards for incoming articles. Responsible for obtaining and negotiating corrective actions with Vendors in relation to incoming article nonconformance in accordance with established procedures and SOPs Responsible for the review and approval of inspection SOPs and quality system documents that pertain to the Quality Control function.
Education and Experience:
Bachelor’s Degree required, preferably in an Engineering or Science discipline
Minimum 10 years of Medical Device Manufacturing Qaulity Assurance experience preferred
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.
Machine, Tools, and/or Equipment Skills:
PC, Microsoft Office, ERP software
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Location/Region: Fort Myers, FL (US)