Quality Engineer - Westborough, United States - SUMERU INC

SUMERU INC
SUMERU INC
Verified Company
Westborough, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Key Responsibilities:


  • Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records.
  • Writes and reviews technical reports and investigation/CAPA memos which are communicated to customers.

Qualifications and Experience:


  • Bachelor's degree required; additional training/education preferred through ASQ (or relevant society) and/or master's level program.
  • Minimum 7 years relevant experience industry experience (e.g., GMP medical device, pharmaceutical) required.
  • Minimum 7 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.)
  • Experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance.

Job Type:
Contract


Pay:
$ $555.00 per hour


Schedule:

  • 8 hour shift
  • Monday to Friday

Work setting:

  • Inperson

Experience:

Post Market Surveillance: 1 year (preferred)

  • CAPA: 1 year (required)
  • ISO 13485: 1 year (required)

Ability to Commute:

  • Westborough, MA required)

Work Location:
In person
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