Our client, a leading manufacturer of medical devices, is looking for a Senior Quality Engineer for their facility in Collegeville, PA.
Some of the benefits to you:
- Competitive compensation
- Benefits package that includes: medical, dental, vision and 401(k) with company match
- Paid time off and holidays
- Greater stability – They recently doubled in size and is investing heavily in their facilities
- Tube-manufacturing equipment, metal deformation machines, laser processing & Swiss machining equipment
- ISO 9001, AS-9100, ISO 13485 certified
- 180,000 sq. ft.
- Metal tube manufacturing and fabrication
- ECM/ECG tube cutting
- Swiss machining
- Laser cutting
- Cleaning and finishing
- BS in Engineering or similar discipline, preferably Mechanical Engineering.
- 7+ years of Quality Assurance experience, preferably in a medical device manufacturing environment or other regulated industry.
- Experience with root cause analysis, DOE, statistics, lean manufacturing, trending, Risk Management, and Six Sigma methodologies. Proficient in Microsoft Office and Minitab. Familiarity with metals processing and the Toyota production business model helpful, but not required.
Please click Apply or email your information to: firstname.lastname@example.org
Essential Job Functions:
- Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
- Monitors manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.
- Reviews the adequacy and correctness of changes to Bills of Material (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
- Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent recurrence.
- Reviews quality data for potential CAPA’s, including analyses of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analyses.
- Assists with product transfers.
- Works with suppliers, management, engineers and manufacturing associates in the resolution of quality problems through capability studies and the application of statistical quality control, including Cpk, DOE, Hypothesis Testing, etc.
About the company: With over 35 years of medical device molding experience, they have become a comprehensive solutions provider for single use medical devices. Services range from concept and design of components to assembly of finished products. They are headquartered in Foxborough, MA and operate 17 manufacturing facilities in the US, with additional locations in China, Mexico, Costa Rica, Puerto Rico, France, Germany and the UK.
All qualified applicants will receive consideration for employment without regard to the individual's race, color, sex, national origin, religion, age, disability, genetic information, status as a military veteran or any other characteristic protected by applicable law.