Job Description

A leading Medical Device company in Irvine, CA is seeking a Project Manager consultant to join their team ASAP for a project that will go for approximately 6 months . This consultant will need to be onsite every day . The PM will report to a leader within Corporate Regulatory Affairs.

This role will focus on the Quality Management System Regulation (QMSR 21 CFR 820) . We need a hands-on individual who is not only willing to lead but also to dive into the details. This consultant will assess the gaps between our current Quality Management System (QMS) and the new QMSR. In addition, the consultant will work closely with multiple stakeholders, including procedure and instruction owners, who will be affected by this change. Primary responsibility will be to ensure that the organization is fully compliant with the new rule by February 2, 2026.

Responsibilities and Duties:

• Assess/determine the quality management system gap assessment by reviewing existing QMS procedures and documentation to the requirements of the QMSR.
• Recommend best route to implement QMSR requirement into QMS by suggesting improvements, documentation edits, and additional documentation to meet the QMSR.
• Execute on the changes by updating impacted procedures/instructions.
• Manage interactions with those impacted by the change.
• Lead presentations with leaders informing them of the progress.
• Lead/support training for employees emphasizing the new changes and how we have addressed.
• Lead/support the mock assessment of changes.
• Manage the complexity around multiple initiatives (for example, business divestiture and Windchill replacing Ignite) that may require changes to the same documents being impacted by QMSR. Therefore, consolidation of those changes might be necessary to ensure everything is streamlined and consistent.
• Edit the QMSR Quality Plan, as needed.

Qualifications:

• Bachelor’s degree minimum
• 10 years of experience in the medical device industry
• Deep level of understanding of ISO 13485:2016 standard and 21 CFR 820
• Project management experience leading multiple successful projects
• Windshield experience
• Understanding of ISO 9001:2015 (clause 3 only) preferred

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