Hiring for Project Manager – Quality in Irvine, CA
Project Manager – Quality (Medical Device)
Location : Irvine, CA (100% onsite)
Long term Contract
Summary :
Seeking a senior Project Manager to lead Quality Assurance (QA) deliverables for a strategic M&A program within the medical device industry. This role drives cross-functional alignment across QA, RA, CA, and R&D while ensuring compliance with FDA, ISO, and global quality requirements.
Key Responsibilities :
- Lead project teams, define deliverables, and manage schedules / budgets.
- Capture requirements, develop project plans, and manage scope changes.
- Identify and close risks / issues while ensuring stakeholder alignment.
- Oversee QA activities, review deliverables, and ensure regulatory compliance.
- Report project performance and drive continuous improvement.
Qualifications :
5+ years Project / Program Management in Quality within medical devices (required).10+ years PM experience in medical devices (preferred).Experience supporting QA in M&A environments (preferred).Strong knowledge of FDA / ISO regulations and QMS.PMP or similar certification (preferred).