Director - QA

Main Objective:

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

Essential Duties and Responsibilities:

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

  Manufacturing Quality Engineering, Sterilization, Quality Control, Validation, Calibration, 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/QC support, inspection efficiency, supplier technical QA relationships, team training and documentation.
• Manage the operating budgets 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.

   

   

  Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

Bachelor’s degree in an Engineering or related discipline, with extensive experience (10+ years) in the technical and leadership aspects of Quality Assurance and Quality Control is required.

Extensive experience in Quality Assurance activities within a regulated, Medical Device, and/or GMP/ISO compliant organization is desired. Experience working with International regulatory bodies and with the FDA is desired.

Direct experience as a Manager/Director with leadership / supervisory responsibilities (>25 people) in a manufacturing environment required (a minimum of 10 years relevant management experience required).

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

In-depth knowledge of quality assurance techniques, practices, ISO and Regulatory (FDA) compliance.

Ability to manage a diverse department, and develop personnel in accordance with company objectives. Training and or certification in Lean/Six Sigma is desired. ASQ Manager of Quality & Organizational Excellence Certification is a plus.

Machine, Tools, and/or Equipment Skills:

Personal Computer skills including but not limited to Microsoft Office, Pilgrim Smart Solve, SAP, and Agile are desired, as well as a general understanding of precision test and measurement equipment.

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.