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Quality Engineering Manager in Ave Maria, FL ,  at Arthrex

Date Posted: 4/12/2019

Job Snapshot

Job Description

Requisition ID:
Quality Engineering Manager
Arthrex Manufacturing Inc
Ave Maria, FL

Main Objective:

Responsible for ensuring that the Manufacturing Quality System is effectively established, deployed, maintained, and continually improved.  Works closely with Operations Management to drive and maintain world class manufacturing operations and quality outcomes.  Manages, directs, and mentors the efforts of QA Engineering and QA Technicians.  Monitors and reports on the performance of the quality system to management and establishes the format and frequency of these reports.

  • Has overall leadership responsibility for the Manufacturing Quality Assurance department, including

    Manufacturing Quality Engineering, QA Technicians, and other related activities as assigned.

  • Responsible for maintaining a Manufacturing Quality System that is in compliance with worldwide medical device regulations, including FDA Quality System Regulations and European Medical Device Directives.
  • Responsible for Manufacturing QA support, inspection efficiency, supplier technical QA relationships, team training and documentation.
  • Manage the operating budget for Manufacturing Quality Assurance Department.
  • Participate in the design control process as it relates to the transfer of new designs to manufacturing, and the maintenance of existing designs.

Essential Duties and Responsibilities:

  1. Manages and directs the efforts of the Quality Control Inspectors and Quality Control Supervisors.
  2. Supervises Quality Engineers and Quality Assurance Technicians assigned to manufacturing departments work activities to provide timely and efficient flow of services and projects.
  3. 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.
  4. Evaluates and develops improved quality techniques for the control of product activities.
  5. Timely dispositions Material Review Board and Corrective Action issues
  6. Reviews, approves and coordinates intradepartmental approval of internal and externally generated deviations, maintain log of same.
  7. Reports progress and status of projects on a timely basis with emphasis on reporting results to the Director, Quality Assurance and Manufacturing Engineering Manager.
  8. Responsible for interfacing with Vendors regarding discrepant incoming articles and coordinating MRB efforts
  9. Responsible for assuring the integrity and completeness of Device History Files
  10. Responsible for staffing, positioning, hiring and disciplinary action (as necessary) the Quality department
  11. Responsible for maintaining and equipping the inspection department to meet the needs of tests and inspections required by new and modified products
  12. Responsible for assuring First Article Inspections are completed by Vendors for all new/modified articles
  13. Responsible for assuring QC Inspectors are properly trained in all inspection equipment and techniques, procedures and SOPs
  14. Responsible for maintaining efficient work flow, work assignments and throughput standards for incoming articles.
  15. Responsible for obtaining and negotiating corrective actions with Vendors in relation to incoming article nonconformance in accordance with established procedures and SOPs
  16. 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 QA experience required, Medical Device Manufacturing or similar regulated environment  preferred

3 Years of direct Management/Supervisory experience required

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.