Role details

Quality Engineering Manager - ISO13485

Westborough   •  Permanent

Bullet points

  • OEM Medical Device Company
  • ISO13485 experience required; BS in Engineering Required

About Our Client

Our client is a growing contract manufacturing medical device company located near Westborough, MA. Though still small, the company has a profound sense of community and treat their employees well which result in very little turn over and a happy work environment. The position for the Quality Engineering Manager will carry a lot of authority and lead efforts to streamline ISO 13485 processes as well as new product development initiatives.

Job Description

The Quality Engineering Manager will:

  • Provide Quality Engineering leadership in direct support of medical device manufacturing.
  • Management and development of subordinates.
  • Manage the ISO13485 quality system and document control program.
  • Ensuring successful planning, management and execution of area projects.
  • Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.
  • Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.

The Successful Applicant

The Quality Engineering Manager should possess:

  • 4 year degree; industry certification or advanced degree, electrical or mechanical engineering preferred.
  • 5+ years in quality desired with roles of increasing responsibility, impact, and scope within a manufacturing support environment.
  • Demonstrated experience working with ISO 13485 systems and document control programs.
  • Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.

What's on Offer

  • Great team culture and upper management
  • Leadership role
  • Very little "red tape"
  • Work/Life Balance

Apply for this job

Click the Apply or LinkedIn button below or contact Morgan Bernstein quoting job reference 1211229
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