Project Quality Manager - Medical Device

Talent is working with a startup company that is looking to help cell and gene therapy companies meet their key product QC requirements by providing fast and actionable multi-parameter results using their tabletop instrument and a room temperature stable cartridge.

Our client is looking for a motivated quality documentation writer to be a Project Quality Manager. Using high quality documentation, you will manage process control of multiple products.

Responsibilities

• Standardize high-level, as well as more detailed, quality procedures and work instructions (WIs), including creation of templates, where necessary.
• Review weekly updates to identify opportunities for process control and participate in quality team and cross-site meetings relevant to areas of responsibility.
• Help compile input for management review meetings.
• Assist the Director of QA and Regulatory Affairs in CAPA processing across sites.
• Providing input for drafting validation test design/protocols.

Requirements

• BS or higher preferred in Life Sciences
• 5+ years of QA/regulatory work experience (knowledge of ISO 13485 manufacturing environment is ideal)
• Prior procedure writing experience
• Knowledge of CAPA process is an advantage
• Experience using and extracting data from a PLM or ERP is a major advantage