Company Type
Medical Device Manufacturer
Location
Portland, Oregon
Job Description
- Support and manage the verification system at Medical Tubing Products for new and existing products. This will involve the support of a 1st Article inspection program and/or process capability studies, measurement system analysis (such as gage R&R), statistical process control, and inspection audits to verify quality levels.
- Create Quality Inspection Plans for in-process, final, and receiving inspection.
- Support process validation studies for special processes and drive a reduction in Medical Products’ reliance on inspection as a quality assurance methodology.
- Develop standard quality inspection procedures and methods.
- Work to affect Cost of Quality improvement projects
- Resolution of customer complaints utilizing the 5 whys or other quality complaint resolution tool. Partnering with suppliers and company manufacturing facilities on problem resolution.
- Be a resource for design of experiments (DOE) and capability studies.
- Establish process metrics to evaluate process performance, define control points, and work with engineering, and manufacturing to ensure that minimum expectations are met.
- Support Product Development and Manufacturing Engineering as required in new product introduction and assure product meets customer requirements.
Job Skills
- Three or more years quality engineering experience in order to plan, establish and coordinate test and inspection procedures, conduct process capability studies, prepare statistical quality control data and develop statistical designed experiments.
- Masters of Science/Engineering with two or more years of quality engineering experience.
- PhD with limited experience
- BS in science, engineering, manufacturing or technical discipline, CQE, or equivalent Experience.
- Maintains current knowledge of relevant new technologies, materials, equipment, and processes. Applies knowledge to continually enhance company capabilities.
- Proactive in improving processes and procedures.
- Works effectively on a team; helps in creating a fun and productive work environment
- Demonstrated ability to learn from successes and failures
- Passion to “do what is right” in tough situations
- Knowledge of FDA 21 CFR Part 820 and ISO 9001 and/or 13485 preferred
Job ID: 5540
Categories
Engineer, Quality Assurance, Quality Control Engineering, West Coast
