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Quality Engineer - Medical Device


Due to continued growth,our client is looking for a?Quality Engineer?to join their?Brimfield, MA?team. The quality department takes pride crafting high-quality, medical devices that save or enhance lives. This primary responsibility of this role is to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance. Provide work direction for 1-3 Technicians/Inspectors.



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



Facility highlights:



  • 51,000 sq. ft.

  • Five CNC Swiss machines, five 5-axis CNC milling machines, 38 3- & 4-axis CNC milling machines

  • FDA registered, ISO 13485 certified


Capabilities:



  • High-precision metal multiaxis milling

  • Wire EDM

  • TIG welding

  • CNC turning/turn-mill

  • Swiss machining

  • CMM inspection

  • Delicate polishing & instrument assembly

  • Product & process development



Key Accountabilities and Responsibilities:



  • Adheres to Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.

  • Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.

  • Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.

  • Review the adequacy and correctness of changes to Bill of Materials (BOM?s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.

  • Lead generation and completion of protocols and reports for test method validations.

  • Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.

  • Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.

  • Ensure that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.

  • Lead and manage complaint investigations.

  • Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.

  • Participate in continuous improvement projects.

  • Assist with product transfers.

  • Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, assists each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.

  • Mentor and support quality inspectors and technicians


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.


Qualified candidates must have:



  • Bachelor of Science degree in Engineering or technical field

  • 2-5+ years quality engineering experience, preferably in medical device or regulated manufacturing

  • Good knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)

  • Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six Sigma Green Belt or Black Belt desired


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