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  • South Plainfield, NJ 07080

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Manufacturing Quality Engineer

WorkRocket • South Plainfield, NJ

Posted 8 days ago

Job Snapshot

Engineering, QA - Quality Control


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Job Description

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.

They are looking for a Quality Engineer to join their highly skilled team in South Plainfield, NJ.

Reporting to the RA/QA Director, 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 there as they are a large organization that offers room for professional advancement and hire/promote heavily from within.

Highlights of the South Plainfield facility:

  • 15,000 ft² clean rooms
  • Tooling center of excellence
  • Two-shot injection molding
  • Insert, over molding
  • Complete device assembly & packaging
  • Staples manufacturing
  • Staples semi and automated cartridge loading
  • Value added services: Pad printing, UV/solvent/adhesive bonding, packaging, blister and pouching, electromechanical assembly, ultrasonic welding, statistical process control
  • FDA Registered, ISO 13485

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:
They are a leading provider of highly engineered custom plastic processing solutions serving the global Healthcare market. They are headquartered in Tempe, Arizona and operate ten manufacturing facilities in the US, with additional operations in China, Mexico, Costa Rica, Puerto Rico, 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.

Job Requirements

If you have a Bachelor's degree (BA/BS) from accredited four-year college or university and minimum three years of work experience in a manufacturing environment, our client definitely wants to hear from you!  Experience should include medical device industry experience in engineering, preferably in quality assurance role.  Previous supervisory experience preferred.

Please click Apply or email your resume to: [Click Here to Email Your Resumé] and include 'WR15748 - Quality Engineer' in the subject line, or your resume may be overlooked.

Job ID: WR15748
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