Quality Assurance Project Manager (Irvine)

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).