Senior Complaint Manager

vor 1 Tag

Therwil, Schweiz Sentec Vollzeit

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.

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