Position: Project Manager
Location: Remote
Experience: 10+ Years
Duration: 12+ months
Citizenship Requirement: US Citizen only
Overview:
We are seeking a Project Manager with deep expertise in Design Control and proven experience leading quality system integrations across organizations. This role requires strong knowledge of Design Control processes and terminology, combined with the ability to drive cross-functional teams and ensure successful integration of systems.
Key Responsibilities:
Lead the integration of one company s Design Control system into another organization s QMS.
Conduct gap analyses of SOPs and DHF evidence to identify overlaps and deficiencies.
Determine where existing protocols/reports can be leveraged and define where new processes are needed.
Coordinate with cross-functional partners, including Design Assurance, R&D Engineers, and other stakeholders, to implement solutions.
Act as the driver of the program, ensuring progress and alignment, rather than taking direction from the partner organization.
Qualifications:
Bachelor s degree in Engineering, Life Sciences, or related field.
Extensive knowledge of Design Control principles, terminology, and FDA/ISO regulatory expectations.
Demonstrated experience with QMS integration projects, particularly in Design Control.
Strong project management skills with the ability to lead cross-functional teams.
Excellent communication and organizational skills.
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