Quality Compliance Manager overseeing compliance implementation and project management in medical device industry. Strong experience in Quality Management Systems and cross-functional collaboration is required.
Responsibilities
Developing and managing sites’ project plans for implementation of ECMP workstream outputs;
Tracking progress and ensuring execution according to plan;
Reporting sites’ progress to ECMP Program Management Office (PMO);
Being responsible for ECMP documentation and schedule at sites;
Coordinating collaborative activities between sites’ local activities;
Periodically reviewing the outputs from the sites’ work stream activities to ensure it is aligned with requirements of the ECMP and individual site’s project plan;
Facilitating resolution to issues
Other duties as assigned.
Requirements
Bachelor's degree is required, (Engineering, Science or closely related technical discipline is preferred)
10+ years of experience leading a team (indirect reports and/or projects) or equivalent education and years of management experience.
Experience working Quality Management Systems and understanding compliance.
Experience in medical device industry required, including material remediation experience.
Experience in implementing remediation programs, and working with compliance frameworks such as FDA, ISO 13485, and EU MDR.
Demonstrated management and communication skills.
Proven track record of cross-functional collaboration across teams and change management skills.
Strong attention to detail skills
Strong communication and presentation skills, with the ability to articulate program status and risks to key stakeholders.
Ability to travel up to 50% if needed based on site needs.
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