Quality Assurance

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Quality Assurance

Katalyst Healthcares & Life Sciences

Posted on: 24 Mar 2024

Job Location: Westborough, US

Job Description:

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

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

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.)