Senior Quality Assurance Engineer - Katalyst Healthcares & Life Sciences
West borough, MA 01581
About the Job
Responsibilities:
- Interface with customers in various forms of communications including regional forums and specific customer touchpoints, as requested by various teams in the field. Provide data and analysis for customer specific meetings.
- Proactive Failure Mode Trending to identify emerging issues across various Westborough product groups and provides analysis around failure mode signals, root cause investigations, and subsequent corrective actions
- Support in CHU complaint handling and QA product investigations as deemed appropriate by management
- 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
- 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
Source : Katalyst Healthcares & Life Sciences