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Senior Complaint Manager

Senior Complaint Manager

SentecTherwil, BL, CH
Vor 30+ Tagen
Anstellungsart
  • Vollzeit
  • Quick Apply
Stellenbeschreibung

Join our team as a Senior Complaint Manager.

Sentec is a Swiss-American medical device company specializing in respiratory care. Since its founding in 1999, the company utilizes deep-tech to develop and manufacture avant-garde technology for complex respiratory patients. Sentec provides healthcare professionals worldwide with non-invasive, accurate monitoring and effective therapeutic solutions.

Your Mission

As our Senior Complaint Manager you will :

Manage and continuously improve the Customer Complaint process :

  • Drive efficiencies and implement process improvements within the Quality organization.
  • Develop and maintain QMS work instructions for complaint file management and post-market surveillance.

Ensure effective complaint file management :

  • Oversee timely entry, review, investigation, and closure of complaints in the QMS.
  • Perform initial risk assessments and escalate medium- or high-risk complaints to Clinical and Regulatory Affairs.
  • Lead complaint review meetings :

  • Organize and facilitate regular complaint review meetings.
  • Analyze and communicate complaint trends :

  • Prepare and report on complaint trend analyses in alignment with Post-Market Surveillance procedures.
  • Act as a regulatory representative :

  • Provide data and insights during audits, product recalls, and Field Safety Corrective Actions (FSCAs).
  • Contribute to QMS initiatives :

  • Support broader QMS projects, including CAPAs and NCRs, as needed.
  • Provide product and process guidance :

  • Offer guidance on product and service failures and recommend improvements.
  • Requirements

    Education and Experience :

  • Bachelor's degree in Life Sciences, or a related field (advanced degree preferred).
  • Minimum 5 years of experience in complaint management, quality assurance, or a related function within the medical device or healthcare industry.
  • Technical Skills and Knowledge :

  • Strong understanding of Quality Management Systems (QMS), including complaint handling, post-market surveillance, and regulatory requirements (e.g., ISO 13485, FDA 21 CFR 820).
  • Proven experience with complaint investigations, root cause analysis, and risk assessment methodologies.
  • Excellent verbal and written communication skills in English (German is a strong plus).
  • Policy for unsolicited applications from recruiters and recruitment agencies

    We do not accept any unsolicited applications from recruiters or recruitment agencies without a prior written agreement between both parties. Therefore, we will not be liable for any commission, fee, or expense for candidates submitted spontaneously. Any application sent without a prior agreement will be considered a direct application and will not be subject to any commission rights.