Quality Engineer - 0366
Job Title: Quality Engineer
Location: Bedminster, NJ (07921), will be expected to work remotely as needed
Duration: 12-month contract
Compensation: Varies depending on experience
Benefits: Real Staffing offers medical, dental, vision, 401k, voluntary life insurance, and short term/long term disability
The position will require travel with third party manufacturing locations in upstate New York, Vermont, and Ireland as needed (20-60%). There is potential for travel to client's locations (Madison WI, St. Louis MI, and Dublin Ireland).
The Quality Engineer will support evaluation and implementation of manufacturing process changes for complex medical devices working directly with Contact Manufacturing Organizations (CMOs) and CMO Managers. This role will also support day-to-day production and continuous improvement activities in the manufacture and release of medical device products. The Quality Engineer will represent the Quality function in teams and will support projects / teams with minimum supervision and guidance.
General Job Responsibilities:
- Provide quality-engineering support between contract manufacturers and internal stakeholders
- Apply experience in design controls, manufacturing transfer, change control, and medical device verification / validation
- Facilitate investigations and root-cause analyses with suppliers and internal departments to recommend necessary corrective action(s) to eliminate current problems and prevent future problems
- Work closely with external manufactures to gather information and assess / process proposed changes in alignment with internal change control processes
- Compile / collate and share or present information / data through reports and follows up on projects, change initiatives, and improvement opportunities
- Draft training material (Standard Operating Procedures, Work Instructions, etc.)
Required Education / Experience / Skills:
- Bachelor's degree in Engineering, Medical Technology, Life Sciences or a related scientific field
- 3+ years medical device quality engineering, product engineering, or manufacturing engineering
- Strong data driven communication, analytical, and problem-solving abilities
- Working knowledge of 21CFR820, ISO13485, ISO14971
- Applied experience with Quality and Risk Management tools such as Root Cause Analysis, Quality Control Plans, Design Verification & Validation, Manufacturing transfer, Qualification, Process validation, Process Optimization, Experimental Designs, FMEA
- Demonstrated knowledge and experience applying statistical tools / techniques with statistical / data analysis computer applications (e.g. Minitab, Microsoft Excel)
- Ability to read and interpret technical drawings / engineering specifications, and analyze / evaluate computer-generated reports
Sthree US is acting as an Employment Business in relation to this vacancy.