Quality Compliance Manager, ECMP Site Facilitator jobs in United States
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Integra LifeSciences · 1 month ago

Quality Compliance Manager, ECMP Site Facilitator

Integra LifeSciences is a company dedicated to innovating new treatment pathways in healthcare. The Quality Compliance Manager, ECMP Site Facilitator is responsible for overseeing the implementation of the Enterprise Compliance Master Plan at various sites, ensuring project plans are executed on time and coordinating activities between sites.

BiotechnologyHealth CareLife ScienceMedicalMedical Device

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

Qualification

Quality Management SystemsCompliance frameworksMedical device experienceChange managementProject managementCommunication skillsAttention to detailCross-functional collaboration

Required

Bachelor's degree is required
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 highly regulated industries required
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
Regular on-site presence at designated facilities within scope of responsibilities
Strong computer skills are required

Preferred

Engineering, Science or closely related technical discipline is preferred
medical device and/or pharmaceutical preferred, including material remediation experience

Benefits

Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))

Company

Integra LifeSciences

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Integra LifeSciences is an integrated medical device company.

Funding

Current Stage
Public Company
Total Funding
$350M
2018-05-15Post Ipo Equity· $350M
1995-08-25IPO

Leadership Team

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Mojdeh Poul
Chief Executive Officer
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Lea Knight
EVP and Chief Financial Officer
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Company data provided by crunchbase