Quality Engineer

Warsaw Area, IN

Posted: 10/30/2018 Industry: Medical Device Job Number: 2630 Pay Rate: $45,000-$100,000

Quality Engineer

Highly Respected Medical Device Company is seeking a Quality Engineer with significant upside to join their quality team. This is a new position within the company and has high visibility among customers and the entire production team. The Quality Engineer is responsible for the quality assurance of all products, quality system management, and manufacturing process quality and customer problem resolution. The QE is also responsible for being the resident expert in GD&T, supporting continuous improvement activities and all results related to product quality, performance and safety. This position reports directly into the Director of Quality.

 

 

Quality Engineer Responsibility

New Product Review

  • Determine/approve inspection best method for medical implants and surgical instruments.
  • Determine/approve Inspection frequency based on criticality.
  • Work with Engineering/Production/ Customers to revise or change dimensional scheme in prints to ease manufacturing/Inspection and reduce costs.
  • GRR/Correlation as required by customers

Gauge Design

  • Develop concepts for go, /no-go gauges, functional gauges, Inspection Fixtures.
  • Approve gauge/fixture design

Existing Product

  • Reassess inspection methods as needed for inspection effectiveness.
  • Identify problem inspections in production, use lean principles and quality tools to increase inspection productivity

 

Procedures

  • Determine Inspection best practices and inspection by feature type and create guidance documents when needed.
  • Carry out Inspection reduction initiatives, capability studies, GRR’s, onboard new equipment

 

Compensation is based on knowledge and experience. $45,000-$100,000

Minimum 5 years in a Quality Engineering role either Medical device or Aerospace.

For immediate consideration and interview please contact Jeff Elzinga for details 239-301-3448

Minimum Requirements-

  • Medical/Aerospace or other regulated industry background. 
  • Solid knowledge of GD&T and print reading
  • Solid knowledge of best inspection practices with Indicators, Calipers, Micrometers,    Comparators, Vision systems and CMM’s etc.
  • Hands on inspection/fixturing knowledge of complex parts required.
  • Familiar with Lathe, Swiss, Mill 4 and 5 axis machining operations

Paula Morisey
Research & Recruitment Specialist

Paula joined the Morisey-Dart Group in August of 2017. She is the firm’s research and recruitment specialist for the medical device and precision machining/manufacturing teams. She is responsible for sourcing and recruiting, lead generation, internet research and various other responsibilities within both the medical device and precision machining industries.

With 25 years at Xerox Corporation in New York, Paula had a prosperous and noteworthy career where she excelled during her tenure. She brings her vast knowledge and expertise in procurement, supply chain, contract administration and project management to the firm. She is a creative and natural problem-solver with proven success in developing and implementing new procedures and processes as well as integrating newly acquired subsidiaries.

Now, she’s using her expertise to build a network of solid relationships in the medical device and precision machining industries that help hiring managers find the top talent they need to improve their organizations.

Paula is Lean Six Sigma certified (Green Belt), has a Master of Science in business management and a Bachelor of Science in education.

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