Quality Compliance Manager, ECMP Site Facilitator

Integra LifeSciences•Mansfield, MA

28d•$109,250 - $149,500•Hybrid

About The Position

The Quality Compliance Manager, ECMP Site Facilitator, provides tactical support and oversight of the implementation of the Enterprise Compliance Master Plan at Integra LifeSciences sites. They are responsible for developing individual site project plans derived directly from the Enterprise Compliance Master Plan (ECMP), and ensuring that the project plans are being implemented according to the defined timeline and plan. Site Facilitators will work closely with existing site Quality and Operations leaders and may have responsibility for more than one site. The Quality Compliance Manager, ECMP Site Facilitator will be traveling between our three (3) sites as needed (Añasco, Puerto Rico; Mansfield, MA; Cincinnati, OH occasionally) and the established on-site primary location needs to be Mansfield, MA.

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
Regular on-site presence at designated facilities within scope of responsibilities
Residence requirements: Mansfield, MA

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