Role details

Quality Engineer - ISO 13485

Stoughton   •   USD60,000 - USD75,000   •  Permanent

Bullet points

  • Growing organization with career advancement opportunities
  • ISO 13485 experience required

About Our Client

Our client is a manufacturing company that services the medical device industry. This particulat location is part of a larger organization which is on the S&P 500. Solid financially and in a growing state, this is a great opportunity for a quality engineer to join their team.

Job Description

The Quality Engineer will have responsibilities that include:

  • Manage quality assurance activities associated with manufacturing, including development, implementation of inspection plans and product testing
  • Manage remediation of customer complaints relating to Brockton production
  • Manage the Management Review process
  • Manage the CAPA process to ensure comprehensive and effect solutions
  • Participate in design quality reviews & development of new product risk management plans
  • Create & maintain quality system documentation

The Successful Applicant

The Quality Engineer should have skills that include:

  • BS in Science, Engineering or Busines
  • Knowledge of engineering drawings & specifications
  • Knowledge of ISO 13485 requirements
  • Measurement & mathematics skills including statistical analysis
  • Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio) & Minitab
  • Strong verbal & written communication skills & attention to detail

What's on Offer

  • Growing organization
  • close-knit team
  • strong leadership from upper management

Apply for this job

Click the Apply or LinkedIn button below or contact Morgan Bernstein quoting job reference 1198489
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