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.
Application Instructions: Please apply using the form or send your resume to Debbie Winkelbauer.
