Integra LifeSciences

Quality Compliance Manager, ECMP Site Facilitator

Integra LifeSciences

full-time

Posted on:

Location Type: Office

Location: Mansfield • Massachusetts • Ohio • United States

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Salary

💰 $109,250 - $149,500 per year

Job Level

SeniorLead

About the role

  • 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))
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
project managementquality management systemsremediation programscompliance frameworksFDAISO 13485EU MDRdocumentation managementschedule managementprogress tracking
Soft Skills
leadershipcommunicationcollaborationchange managementattention to detailproblem-solvingpresentation skillsstakeholder managementteam managementorganizational skills