What You'll Be Doing:
- Maintain and improve quality system through database management and analysis of quality data to various quality certifications and standards. Monitor and audit processes and make improvements in quality where necessary to assure standards are being met. Works with other departments to identify and resolve quality issues. Provides Corrective Action when quality issue arises.
- Manage the quality assurance department activities within the site. Maintain and continually improve the quality system, using data to define opportunities for improvement. Drive process improvements. Maintain ISO AS9100 and 13485 certifications
- Manage control of the documentation process, the internal quality audit and inspections systems, and the calibration system.
- Work with other departments to maintain statistical process control of the site's processes.
- Maintain and improve Field Quality Report (FQR) customer complaints system.
- Along with other department heads, drive compliance to the annual Business Plan's key metrics. Interface with external customers regarding quality issues. Assure prompt resolution to issues.
- Train applicable workers on Quality- related areas, such as 5S, Lean, SPC, etc.
What We're Looking For:
- 2-4 years in quality engineering, quality systems and processes
- Experience with QMS systems
- Experience in medical, aerospace, electronics/semiconductor industries, a plus
- Experience in the following quality methodologies:
- Six Sigma
- Root Cause
- Corrective Preventive Action
- Engineering Change Control
- Quality Function Deployment
Experience / Education
- Typically requires a 4 year degree and 2–4 years of related experience; or an advanced degree without experience; or equivalent work experience.