Provides leadership and technical support for the quality assurance, process control, and engineering functions. Leads or is a key contributor to cross functional process improvement and problem solving teams.
- Supports Quality management, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time, and that internal audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule.
- Coordinates and completes all tasks and documentation required for externally supplied component qualifications (First Article Inspections).
- Coordinates technical activities regarding validations: including protocol development, synchronization of interdepartmental activities, evaluation and reporting results.
- Reviews and approves product/process qualification/validation and other change control related documentation.
- Identifies and leads implementation of new opportunities for improvements to work processes, production, QA testing, and other areas as identified.
- Investigates product issues by conducting failure investigations, complaint trending, and Product Inquiries.
- Investigates component issues by conducting failure/root cause investigations and conduct product inquiry reports (PIR), as needed.
- Communicates, interacts and coordinates quality improvement efforts with Manufacturing, QA, R&D, and engineering management regarding product status, deviations and problems; provides testing and training support to Manufacturing, Engineering and R&D.
- Supports the Material Review Board by providing or reviewing the disposition of Non-Conforming Material
- Supports Supplier management, which includes maintaining supplier corrective actions, supplier audits, supplier certification, non-conforming material review and supporting incoming material inspection.
- A Bachelors degree in Engineering, Science or related field is required. A Masters of Science in Engineering, Science or related field is preferred. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable
- A minimum of 3 years’ experience in quality assurance, quality engineering or related functions or a M.S. plus 1 yearexperience is required. Prior experience in a FDA regulated industry or ISO certified organization.
- Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments.
- Working knowledge of quality systems is required. Familiarity with analytical software applications is preferred.
- Project management and leadership experience is preferred. Previous experience supervising technicians and conducting and participating in FDA/customer/corporate audits is preferred.
- Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
- Ability to use Microsoft Office Products such as Word and Excel or equivalent software applications is preferred.