Sorry, this particular job is closed. But feel free to fill out a General ApplicationSearch Jobs
We're currently working with a leading Medical Device manufacturing company in the Fayetteville Area looking for a skilled Quality Engineer to join their team.
- Provide Validation input (DOE, FAT, SAT) to cross-functional teams involving R&D, Marketing, Regulatory, developing medical devices.
- Support line transfers, qualification and verification activities at site
- Support supplier selection activities, address quality issues as they arise
- Develop statistically relevant test methods, protocols and documentation to support manufacturing of medical devices.
- Develop validated plans for joining operations like ultrasonic welding
- Conduct technical reviews; ensure documentation is available to meet Quality Systems Requirements. (BOMs, Routers, FMEAs, etc.).
- Actively participates in concept review and development on new injection-molded products.
- Support various teams and work closely with Design Engineering and Project Management to smoothly transition new products to production. Provide frequent and appropriate communications with all internal customers
- Stay current on core competencies and best practices in manufacturing to ensure incorporation into new qualifications / validations.
- Identify root cause and implements corrective and preventive measures to improve or ensure product quality across product lines.
- Ensure product documentation and manufacturing processes meet all Quality system requirements.
- Designs, installs, and continually evaluate quality assurance and/or control methods and Systems.
- Conduct statistical analysis in the form of capability studies to evaluate processes.
- Develop standards, procedures, and work instructions.
- Apply in-depth knowledge of statistical techniques, with ability to identify, analyze and define possible solutions for continuous product and process improvement
- Perform training in internal auditing, mechanical inspection and statistical techniques
- Develop sampling plans and statistical methods to be utilized by manufacturing and inspection to include determination of control points and charting methods.
- Interface with engineering and CMM programmers to design fixtures and processes to ensure the effectiveness of measurement systems.
- Conduct internal and external audits and supplier surveys to verify capability and/or compliance.
- Coordinate and participate in material review activities to determine nonconforming product dispositions and corrective actions.
- 4 year Engineering Degree and 5+ years of experience in the areas of quality management in the medical device field
- Ability to apply engineering principles to an idea or set of user requirements and then convert this into design requirements, considering manufacturability, cost of goods, and the regulatory requirements for a device or combination product.
- Ability to develop injection molding and Assembly Validation Master plans.
- Expertise in plastics testing – particularly ASTM and ISO mechanical tests.
- Ability to make data-based and risk-based decisions to drive projects efficiently.
- Good understanding of Design for Manufacturability principals, GAMP5, UL and EU electrical standards.
- Expertise of FDA regulations and validation of automation equipment, i.e. SAT, FAT, IQ, OQ, PQ.
- Forklift Operator in Flowery Branch GA
- 2nd shift Production - $13.50-hr. in Bridgeton
- Picking Associate - 2nd Shift in Suwanee GA
- Electrical Assembly in Chaska MN
- Machine Operator- 2nd Shift in Canton GA
- Engineering Technician in Rock Hill SC
- Inspector in Merrimack NH
- Maintenance Manager in Milwaukee WI
- Cylinder Head Engineer in Suwanee GA
- Warehouse Associate-Forklift Operator - 1st Shift in Gainesville GA
- Engineering Technician in Dassel MN
- Plastics Supervisor in
- Project Coordinator in Chaska MN
- Regulatory Affairs Specialist in Chaska MN
- Technical Business Analyst & Project Manager in Miami FL
- CNC Machine Operator in Lawrenceville GA
- Mechanical Designer- Cad Administrator in Wilmington MA
- Electronic Assembler in Alpharetta GA
- Field Mechanical Assembler in Acton MA
- Quality Inspector 2nd shift in Flowery Branch GA
- E-M Assemblers - 2nd Shift in Merrimack NH
- Production Machinist-Assembler - Laser in Milford MA
- Column Assembler in Milford MA
- Shipping & Receiving in Suwanee GA
- ABS Trading System Developer in Costa Mesa CA
- Quality Manager in Dawsonville GA
- CI Manager in Dawsonville GA
- Assembler in Concord CA
- Planner-Scheduler in Milford NH
- Electronics Test Tech in Suwanee GA
- Shipping Clerk in SUWANEE GA
- HR File Clerk - Temp in Alpharetta GA
- Benefits Specialist in Lowell MA
- Warehouse Associate in Suwanee GA
- Spot Welder - 2nd Shift in Canton GA
- Buyer in Burnsville MN
- Supplier Quality Engineer in Plymouth MN
- EH&S Analyst in Central Manchester CT
- TIG Welder - 2nd Shift in Alpharetta GA
- TIG Welder - 1st Shift in Alpharetta GA
- Design Assurance Engineer in St. Paul MN
- Inside Sales Representative in Golden CO
- Manufacturing Welding Engineer in Flowery Branch GA
- Purchaser in Flowery Branch GA
- Quality Inspector II - EM OR RII in Westborough MA
- Cloud APP Engineer IV in Miami FL
- 2nd shift Forklift - $15-hr. in Vineland
- Packer - 1st shift Shipping in Vineland
- MIG Welder in Alpharetta GA
- Sales Service Coordinator in Milford MA
- Customer Education Training Specialist in Milford MA
- Assistant to Safety Director in Memphis
- Quality Inspector in Brooklyn Center MN
- Warehouse Associate-Forklift Operator - 2nd Shift in Gainesville GA
- Controller in Windham ME
- Field Application Technician PA in Duluth PA
- Inventory Controls Analyst in Alpharetta GA
- Field Application Technician GP plant in Brunswick GA
- Reimbursement Support in Cordova TN
- Senior Software Test Engineer in Milford MA
- Mechanical Designer in Alpharetta GA
- Project Engineer in Athens GA
- Controls Engineer in Athens GA
- Machinist in Concord CA
- Technical Writer in Brea CA
- Heavy Industrial Machine Assembler in Milford NH
- Process Engineer in Milford NH
- Warehouse Associate in Buford GA
- Warehouse Clerk in Suwanee GA
- Assembler in Buford GA
- Brazer in Buford GA
- CAD Designer in Minnetonka MN
- Sr. Test Technician in Ayer MA
- TIG-MIG Welder in Flowery Branch GA
- Manufacturing Technician in Ayer MA
- General Technician- Value Add in Flowery Branch GA
- Warehouse Manager in Taunton MA
- AP-Cost Accountant in Brooklyn Center MN
- SMT Operator in Billerica MA
- Inspection Specialist- 1st Shift in West Boylston MA
- Test Technician in West Boylston MA
- Project Engineer in Social Circle GA
- Assembler-Packer 1st Shift in Canton GA
- Packer-Shipper in Billerica MA
- General Manager in Everett MA
- Cold Headed Operator in Alpharetta GA
- Screw Machine Operator in Alpharetta GA
- CNC Machinist-Programmer in Alpharetta GA
- Roll Thread Operator in Alpharetta GA
- Tool and Die Maker in Alpharetta GA
- Finishing Operator in Broomfield CO
- Facility Maintenance Technician in Minneapolis MN
- Quality Technician in Chaska MN
- Inventory Control Associate in Lawrenceville GA
- MIG Welder in Flowery Branch GA
- Maintenance Mechanic - 3rd shift in Lincoln RI
- Distribution Supervisor in Newnan GA
- HR Generalist in Franklin NH
- Design Engineer in Newnan GA
- Solderer in Hudson NH