Role details

Quality Engineer

Danbury   •  Permanent

Bullet points

  • Leading Medical Device Company
  • Newly Created Position, Growing Organization

About Our Client

Leading medical device company

Job Description

  • Work with engineering to understand initial customer requirements and develop methods to inspect products
  • Work with engineering on Product release - Validation (IQ, OQ, PQ), PPAP (PFMEA, Control Plan, Flow Chart and Part Submission Warrant), FAI
  • Improve inspection methodology and techniques- automation of inspection and data gathering
  • Work to eliminate or move inspection to manufacturing to provide immediate feedback on product quality
  • Lead the efforts to Integrate different modules of QMS
  • Facilitate transfer to the new version of ISO
  • Review and revamp Quality Procedures and Work Instructions
  • Perform Internal and supplier audits
  • Help with Onboard training
  • Support Customer Audits
  • Work with Human Resources on Training Management
  • Work with purchasing on Supplier control
  • Provide customer responses - supplier surveys, agreements, REACH, RoHS, conflict of materials
  • Complete CAPAs from customer audit findings
  • Initiate, review and release of Engineering Change Orders
  • Self-starter with the ability to work with minimal supervision

The Successful Applicant

BS Degree in Engineering or educational equivalent plus at least two years of related experience.

The candidate must also be computer literate with proficiency in MS project, PowerPoint, Excel, Word and Minitab or other equivalent statistical analysis software.

CQA Certification is a plus, but is not required.

What's on Offer

Competitive salary plus benefits

Apply for this job

Click the Apply or LinkedIn button below or contact Raymond McSpirit quoting job reference 1199029
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