We are searching for a Quality Engineer with CAPA experience for a global quality consulting company. The Quality Engineer – CAPA will work with one of the world’s medical device leaders running complaints investigations.
Requirements fo the Quality Engineer – CAPA
- Bachelor’s degree in engineering, preferably mechanical engineering
- CAPA experience in a manufacturing facility.
- 2+ years’ experience in a production manufacturing environment.
- Experience: RCCA, 8D, DMAIC, PDCA, SPC, GD&T, ISO9001 or ISO 13485 or IATF16969 or AS9100
- Ability to read and interpret engineering drawings, product specifications and industry standards.
- Mechanical inspection experience using various inspection metrology.
- Knowledge of GD&T and ISO standards and/or similar regulations.
- The ability to travel domestically and internationally approximately 20%.
- Experience with a variety of component manufacturing, production and qualification test processes related to machining, welding casting, molding, stamping, forging, painting, plating, heat treating, assembly and fabrication preferred.
- Lean SS Black Belt certification or ASQ CQE preferred
- Mechanical aptitude for working with tools to perform assembly and testing preferred
Responsibilities of the Quality Engineer – CAPA – Medical Devices
- Lead CAPA – corrective action – initiatives in all areas of the quality, manufacturing and warehouse functions.
- Identify, investigate, and reports deficiencies and causes related to supplier problems and customer complaints.
- Monitor the effectiveness of the improvement process.
- Provide periodic progress reports of the CAPA, complaint and continuous improvement activity.
- Responsible for the quality aspect of the supplier performance dashboard and initiates improvement activity based on indicators identified in the quarterly reports.
- Evaluate and monitor supplier performance to determine actions required for improvement.
- Provide support to the internal audit function to assure quality problems are addressed and eliminated.
: Please apply using the form or send your resume to Debbie Winkelbauer