Compliance Supervisor

vor 1 Tag


Le Locle, Neuenburg, Schweiz Integra Lifesciences Switzerland SAS Vollzeit
Job Description

This position plays a pivotal role in ensuring the quality and compliance of Integra Lifesciences Switzerland SAS. As a Compliance Supervisor, you will be responsible for managing the complaint technicians' team, organizing necessary resources to support activities, and ensuring that goals and objectives are set and followed by every team member in accordance with the company's G&O's.

The ideal candidate will have a minimum of 5 years of professional work experience within a quality assurance or compliance audit environment and a Bachelor's Degree in a related technical discipline. They will also possess strong management skills, as well as excellent communication, organizational, negotiation, and interpersonal skills. Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC MDD, EUMDR, 21 CFR part 820, Canadian, Japanese, Australian, Brazilian regulations, etc., is essential.

You will be working closely with various teams, including Design Quality Assurance, Medical Safety, Product Development, and Post market Surveillance, to ensure seamless coordination and effective implementation of quality indicators. Your ability to interface with internal and external customers, as well as your knowledge of statistical techniques, Agile, Oracle, EtQ, Minitab, Trackwise, and Microsoft office tools, will be valuable assets in this role.

Main Responsibilities:

  • Management of the complaint technicians' team
  • Polyvalence of the team
  • Review and close complaint investigations
  • Implementation and management of complaints procedures
  • Trending and product surveillance
  • Establishment and communication of quality indicators
  • Manage Health Hazard Evaluation when necessary
  • Perform complaint trend analysis according to Integra GSOP
  • Participation in Post Market Surveillance activities
  • Risk analysis activities
  • Support internal audits and third-party audits/inspections

Qualifications:

  • Bachelor's Degree in a related technical discipline
  • Minimum of 5 years of professional work experience in quality assurance or compliance audit environment
  • Experience in a Medical Device manufacturing environment preferred
  • Fluent in French and English
  • Knowledge of Medical device standards and regulations
  • Strong management skills
  • Excellent communication, organizational, negotiation, and interpersonal skills


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