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Quality Assurance Investigator

2 months ago

Westborough, Massachusetts, United States Belcan Full time

Job Summary:

Belcan is seeking a Quality Assurance Investigator to join our team. As a Quality Assurance Investigator, you will be responsible for executing the triage, investigation, and closure of product quality complaints.

Key Responsibilities:

  • Execute the triage, investigation, and closure of product quality complaints.
  • Run trend reports and perform statistical analysis of trends to identify emerging issues across various product groups and provide analysis around failure mode signals.
  • Support in CHU complaint handling and QA product root cause investigations as deemed appropriate by management.
  • Support with tracking major issues and related corrective actions.
  • 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.

Requirements:

  • 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.
  • Demonstrated understanding and application of 21CFR Regulations with respect to Customer Complaints.