Senior Quality Engineer - Medical Device
We are seeking a Senior Quality Engineer to join our team! You will perform clerical and administrative functions in order to drive company success.
The Candidate will perform Quality Assurance/Quality Engineering activities to ensure components, finished products, and processes meet established specifications. Analyze materials and processes, make recommendations, or take action to correct deficiencies.
• Develop Control Plans, Inspection Instructions, and other documents as needed to effectively manage product and process quality, both internally and at the suppliers.
• Develop and review documented operating procedures associated with material inspection or processes.
• Support Engineers to develop manufacturing in-process inspections.
• Perform In-process, incoming, and final inspections.
• Conduct and Review inspections onto tubing extrusions.
• Participate in the review and approval of Document Change Notice.
• Collect, analyze, and interpret statistical data.
• Assist in Design of Experiments and Statistical Process Control to improve processes and products.
• Assist suppliers in developing inspection methods.
• Perform Gage R&R and correlation studies.
• Provide support towards Internal/External Quality System Audits.
• Provide training and assistance to inspectors, technicians, and other Engineers.
• Work with QA Technicians and Engineers to resolve measurement issues.
• Work with Engineers on new inspections, and cross-train other QA technicians
• Design tools and fixtures to support Quality Engineering activities.
• Other duties and responsibilities may be assigned, depending on company needs.
Duke Empirical Inc. is the leader in medical device tubing and catheter components. Our teams focus on Speed, Quality, and Innovation has set the new standard for superior medical device outsourcing.
Santa Cruz, CA
Wed, 12 Jul 2017 16:32:48 PDT