Senior Quality Assurance Specialist

4 weeks ago


Westborough, Massachusetts, United States Katalyst Healthcares and Life Sciences Full time

Key Responsibilities:

As a Senior Quality Assurance Specialist at Katalyst Healthcares and Life Sciences, you will be responsible for interfacing with customers through various communication channels, including regional forums and customer touchpoints. You will provide data and analysis for customer-specific meetings, identify emerging issues through proactive failure mode trending, and support complaint handling and QA product investigations. You will also work with R&D, Manufacturing Engineers, Product Managers, and Supplier Quality to ensure robust triage of product complaints and associated investigations.

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 in the industry (e.g. GMP medical device, pharmaceutical)
  • 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


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