Quality Engineer

3 weeks ago

Somersworth, United States William H Hunter Recruiting Full time
Job DescriptionJob Description

Seeking an experienced Quality Engineer to be responsible for overseeing the continual improvement of medical devices as well as the design and manufacturing of new devices.  Excellent career opportunity. 

 

Responsibilities:

 

  • Develop, document, and implement QA procedures
  • Interpret and assess conformity to regulatory standards
  • Provide analytical investigations and develop root cause for non-conformances
  • Design and specify gauging and test equipment for quality assurance
  • Write protocols, analyze data, and generate summary reports for verifications and validations
  • Lead and participate in design control projects for new and changing medical devices
  • Interface with vendors and customers as required
  • Participate in design reviews, pFMEA, risk management reviews, validations, CAPAs, NCMRs, etc.
  • Conduct supplier evaluations, qualifications, and quality audits
  • Reviewing all lab results and approve product release.
  • Working in a team environment with Quality Department and J- Pac Medical personnel.
  • Supplier Quality Tracking (assist in Supplier Quality Audits as required)
  • backup for inspection and test (incoming, in-process & final)
  • Assisting/Participating in Customer Audits (as needed)

 

 

 

Requirements

 

1.  Bachelor’s Degree.

2.  3 or more years of Medical Device Industry Quality Engineering experience. 

3.  Quality Auditor Certification preferred.

 

 

 

 

William H Hunter Recruiting www.williamhhunterrecruiting.com

 

 

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