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).
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