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

Ensure effective complaint file management:
  1. Oversee timely entry, review, investigation, and closure of complaints in the QMS.
  2. Perform initial risk assessments and escalate medium- or high-risk complaints to Clinical and Regulatory Affairs.

Lead complaint review meetings:
  1. Organize and facilitate regular complaint review meetings.

Analyze and communicate complaint trends:
  1. Prepare and report on complaint trend analyses in alignment with Post-Market Surveillance procedures.

Act as a regulatory representative:
  1. Provide data and insights during audits, product recalls, and Field Safety Corrective Actions (FSCAs).

Contribute to QMS initiatives:
  1. Support broader QMS projects, including CAPAs and NCRs, as needed.

Provide product and process guidance:
  1. Offer guidance on product and service failures and recommend improvements.

Requirements
Education and Experience:
  1. Bachelor's degree in Life Sciences, or a related field (advanced degree preferred).
  2. 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:
  1. Strong understanding of Quality Management Systems (QMS), including complaint handling, post-market surveillance, and regulatory requirements (e.g., ISO 13485, FDA 21 CFR 820).
  2. Proven experience with complaint investigations, root cause analysis, and risk assessment methodologies.
  3. Excellent verbal and written communication skills in English (German is a strong plus).
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