Quality Engineer
1 week ago
**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: $50.00 - $555.00 per hour
Schedule:
- 8 hour shift
- Monday to Friday
Work setting:
- In-person
**Experience**:
- Post Market Surveillance: 1 year (preferred)
- CAPA: 1 year (required)
- ISO 13485: 1 year (required)
Ability to Commute:
- Westborough, MA 01581 (required)
Work Location: In person
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