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Project Quality Manager - Medical Device

Location:

San Jose, United States

Work type:

Direct Hire

Business sector:

Medical Device Pharmaceutical

Job reference:

408

Advertiser:

Tyler Snyder

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

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