Senior GRC Consultant consulting clients on GRC software RiMaGo and implementing risk strategies. Collaborating with development team and conducting training sessions in GRC.
About the role
- 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.
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- savings plan (401(k))
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