-Driving the development and documentation of manufacturing processes with suppliers
-Evaluates manufacturing processes by designing and conducting research/testing; applying knowledge of product design, fabrication, assembly, tooling, and materials; working with suppliers and internal machine shops, and soliciting observations from operators
-Assures product and process quality by designing testing methods, testing finished- product and process capabilities, establishing standards, and validating and/or verifying inspection and manufacturing processes.
-Re-review product quality, including but not limited to, manufacturing processes based on our risk management process (production and post-production feedback).
-Investigate both production and post-production feedback issues.
-Develop positive relationships and work closely with functional managers to create, manage, and implement on-going verification plans.
-Act as consultant to the Quality, Manufacturing and Engineering organizations to improve Quality and Manufacturing processes including changes to processes and products, including engineering and supplier changes and product transfers.
-Provide Engineering expertise requiring advanced/specialized skills and a broad range of quality engineering expertise.
-Understand and drive Lean manufacturing internally and with suppliers.
- An Engineering degree from an accredited four year university is preferred.
- A minimum of 5 years of experience in Quality or Engineering in a manufacturing environment.
- Strong communication and problem solving skills using fundamental engineering concepts
- Desire to work in a dynamic, fast-paced, and hands-on manufacturing environment.
- Ability to develop alternative approaches to solve complex problems
- Very strong oral and written communication skills
- Strong Analytical skills Ability to cope with multiple complex situations daily
- Strong adaptation of concepts, theories, and principles to problems
- Strong background in applying statistical quality control tools for process and product controls, such SPC, Gauge R & R, Process Capability, and FMEA
- Prior experience writing technical specifications is preferred
- Background in CAD/CAM software (Creo, Solidworks, Surfcam)
- Knowledge of manufacturing equipment, components and assemblies Background in an ISO 13485 work environment, including experience with risk management and CAPA (Corrective and Preventive actions).