Role details

Medical Device Sr. Quality Engineer

Burlington   •   USD100,000 - USD125,000   •  Permanent

Bullet points

  • ISO 13485 experience required
  • Incoming Inspection experience

About Our Client

Our client is a highly successful medical device company that is growing throughout the nation. Due to this growth, they are looking to add a Senior Quality Engineer to their team. This is a company that works on both new product development and sustaining engineering. This position is located in their Burlington, MA location.

Job Description

The Medical Device Sr. Quality Engineer will have responsibilities that include:

  • Develop and maintain a quality management system to be compliant with ISO 13485 and FDA QSR requirements for an organization that designs, manufactures and distributes medical devices.
  • Provide quality engineering support to manufacturing scale-up activities to ensure that product processes have been developed appropriately and are transferred to manufacturing in accordance with user requirements, plus corporate and regulatory guidelines.
  • Work with Research and Development during new product start-ups to ensure compliance with design controls, and establish key checkpoints for new products and processes.
  • Manage and communicate quality data from multiple sources to assist in the risk management and risk-based decision processes
  • Manage the corrective and preventive action (CAPA), management review process, and internal quality audit programs
  • Manage Non Conforming Material Reviews and MRB activities

The Successful Applicant

The Senior Quality Engineer should have:

  • Bachelor's degree in Engineering or equivalent
  • Experience managing incoming inspection
  • CAPAs and NCMr expertise

What's on Offer

  • Strong impact on overall company quality program
  • Competitive compensation package
  • Work/life balance

Apply for this job

Click the Apply or LinkedIn button below or contact Morgan Bernstein quoting job reference 1195767
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