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Principal Quality Engineer

Summary Statement

Position Responsibilities

1.      Responsible for design quality assurance on project teams for medical devices, including capital equipment, hardware, firmware and disposables.

2.      Responsible for applying statistical techniques to verification/validation activities and in the area of process controls.

3.      Responsible for Quality Engineering input for the manufacturing operation, to include determination of requirements for the validation of test methods and manufacturing processes as well as receiving, in process and final inspection.

4.      Lead the Nonconforming Material Review process.

5.      Participate in the supplier evaluation process, including supplier audits and development of quality agreements with suppliers.

6.      Quality Assurance review and approval on controlled documents.

7.      Perform review of device history records and release product to finished goods.

8.      Back up duties for sterile release of products for distribution.

9.      Process owner of Risk Management Procedures.

10.  Overall responsibility for the sterilization process, including period validation and assessment of new products for inclusion into the validated sterilization cycle.

11.  Responsible for management of the internal auditing program, to include performing audits, assignment of corrective action, and facilitation of internal audit activities conducted by external parties.

12.  May include up to 10% international travel.

Qualifications

·         Must have strong working knowledge of ISO 13485:2003 and FDA Quality System Regulation

·         Minimum of 10 years experience in Quality Engineering in the Medical Device industry with several years in a senior leadership role

·        Working knowledge and application of statistical analysis including acceptance sampling, hypothesis testing and quality engineering principles

·         QE experience supporting product development and product commercialization

·         Strong verbal and written communication skills

·         Experience managing multiple tasks concurrently

·         Strong leadership, mentoring and decision-making skills

Education

·         BS in scientific discipline or equivalent experience in medical device industry

·         Certification in quality engineering preferred; Six Sigma belt a plus