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Quality Engineer

This is your chance to immediately impact an industry leader and be recognized for your accomplishments. Experience a more rewarding quality career with our client.



Due to demand and business growth,they are?looking for a?Quality Engineer?to join their highly skilled team in?Orchard Park, NY.



The successful candidate will provide technical expertise on a broad spectrum of issues related to medical device production where quality is extremely critical. People?s lives depend on the precision of the products.



This is a unique career opportunity where you will not be stuck in your office or in this role throughout your tenure with our client. You will not be pigeonholed in this career as they are a large organization that offers room for professional advancement and hire/promote heavily from within.



Highlights of the Orchard Park facility:



  • 64,000 sq. ft.

  • Class 8 clean room

  • 73 CNC Swiss machines, 3 wire EDMs, 5 milling machines

  • FDA registered; ISO 13485 certified


Capabilities:



  • Swiss machining

  • Wire EDM

  • Metal injection molding

  • Secondary finishing operations

  • Clean room assembly

  • Packaging and labeling


As a valued team member, you will receive:



  • Above average compensation

  • Benefits package that includes: medical, dental, vision and 401(k)

  • Greater stability ? They recently doubled in size and is investing heavily in their facilities



Primary Responsibilities:



  • Lead Quality Assurance Department?s participation in maintenance and development of quality system documentation.

  • Serve as a Quality Assurance resource to internal and external customers for new product design, design changes, and process development/improvement/validation.

  • Interface with supplier and customer quality representatives on quality issues and assure that effective corrective action is implemented.

  • Promote and implement quality standards and associated quality assurance methods, including inspection processes, test methods, quality plans, documents and reports.

  • Develop verification and validation protocols for product designs and manufacturing processes.

  • Develop, execute and analyze data from quality-reporting measures.

  • Report to management on quality issues and trends.

  • Lead and participate in internal and external quality audits.

  • Manage complaint handling, CAPA, and discrepancy report systems.

  • Author and deliver training material on quality standards and activities.

  • Assure compliance with FDA requirements and ISO standards in association with above activities.

  • Requires some overnight travel (up to approximately 20%).


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.


Requirements:



  • Knowledge and familiarity with OGP (Optical Gauging Product) CMM (Coordinate Measuring Machine) and other measuring devices used to ensure quality and acceptability of the product.

  • Bachelor of Science degree in Engineering or technical field is a plus.


Must be a U.S. citizen or green card holder.



Please click Apply or email your resume to:? Click Here to Email Your Resum?



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