Team Lead Global Complaint Management
vor 11 Stunden
**Job Purpose**
The Team Lead Global Complaint Management is responsible for leading a team of complaint Handling Officers, managing the complaint handling process for Straumann products on a global scale, and ensuring the development and performance of team members. The team lead will ensure compliance with applicable regulations and standards, and drive continuous improvement initiatives to enhance the complaint handling process.
**Key Responsibilities**:
- Manage a team of complaint handling specialists responsible for processing complaints related to Dental Implant Systems
- Ensure compliance with applicable regulations and standards, including but not limited to FDA 21 CFR Part 820, ISO 13485, and MDR/IVDR
- Collaborate with cross-functional teams to investigate complaints and identify root causes
- Develop and implement corrective and preventive actions (CAPAs) to address identified issues and prevent recurrence
- Develop and maintain complaint handling procedures and work instructions
- Monitor and report on complaint handling process metrics and trends
- Support continuous improvement initiatives to enhance the complaint handling process and increase efficiency
- Provide training and guidance to team members and other stakeholders on complaint handling and related topics
- Develop and implement professional development plans for team members
- Monitor the performance of the local complaint handling teams across the globe
- Provide feedback to local teams and escalate performance issues as needed
- Ensure consistency and alignment of complaint handling processes across all regions
**Qualifications**:
- Bachelor's degree in a related field (e.g. engineering, life sciences, etc.). Certification in medical device quality and regulatory affairs preferred
- At least 5 years of experience in medical device complaint handling or related field
- Strong understanding of applicable regulations and standards, including FDA 21 CFR Part 820, ISO 13485, and MDR/IVDR
- Experience in authority and notified body audits
- Experience leading a team or managing projects
- Excellent communication, interpersonal, and leadership skills
- Strong problem-solving and analytical skills
- A team player who is excited for taking on new challenges
- Experience with CAPA management and root cause analysis methodologies
- Proficiency in Microsoft Office (Excel, Word, PowerPoint) and complaint handling software
- Experience with global complaint handling and regulatory requirements in various regions (e.g. EU, APAC, LATAM, etc.)
- Experience with electronic complaint handling systems (e.g. SAP CRM, TrackWise, etc.)
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
**Employment Type**:Full Time
**Alternative Locations**:Switzerland : Basel
**Travel Percentage**:0 - 10%
**Requisition ID**:9161
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