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ININTEGRA LIFESCIENCES CORP

Quality Compliance Manager - ECMP Site Facilitator(m/w/x)

Le Locle, Rietheim-Weilheim
Full-timeOn-siteSenior

Implementing compliance frameworks like FDA/ISO 13485 for remediation programs at medical device sites. 10+ years team leadership in highly regulated medical device industries required. Travel across multiple sites.

Requirements

  • Bachelor's degree in Engineering, Science, or related technical discipline
  • 10+ years of experience leading a team or equivalent education and management experience
  • Experience working with Quality Management Systems and compliance
  • Experience in highly regulated industries, medical device and/or pharmaceutical preferred
  • Experience in implementing remediation programs and compliance frameworks such as FDA, ISO 13485, and EU MDR
  • Demonstrated management and communication skills
  • Strong attention to detail
  • Strong communication and presentation skills
  • Ability to travel up to 50% if needed
  • Strong computer skills

Tasks

  • Develop and manage project plans for ECMP implementation
  • Track progress and ensure execution according to the plan
  • Report site progress to the ECMP Program Management Office
  • Manage ECMP documentation and scheduling at sites
  • Coordinate collaborative activities between local site teams
  • Review outputs from site work stream activities for alignment with ECMP requirements
  • Facilitate resolution of issues
  • Perform other assigned duties

Work Experience

  • 10 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • FDA
  • ISO 13485
  • EU MDR
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