Global Complaint Resolution Manager bei Sentec

The Global Complaint Resolution Manager is responsible for leading the complaint handling process and post-market activities for active medical devices, with a focus on high-risk and high-complexity cases. This role provides functional leadership to a team of complaint specialists, ensuring regulatory compliance, process optimization, and continuous improvement. The position includes training and mentoring the team, managing Field Safety Corrective Actions (FSCA) and recalls, and supporting trend analysis. This position is based in Lincoln, RI and will work closely with, and as an extension of, the Sentec AG and Percussionaire Inc. Quality Assurance teams.

Essential Duties and Responsibilities:

Complaint Handling & Team Leadership

• Serve as process owner for the global complaint handling system
• Functionally lead and mentor a team of complaint specialists
• Oversee complaint intake, documentation, and classification
• Escalate potentially reportable events to Regulatory Affairs

Post-Market Surveillance

• Manage operational tasks for FSCA and product recalls
• Focus on resolution of high-risk and high-complexity complaints
• Support QA in monitoring and identifying complaint trends

Cross-Functional Collaboration

• Work closely with Service, QA, Regulatory Affairs, and Clinical Application Specialists to assess failure modes and track high-risk complaints and associated actions
• Conduct error and problem analysis in collaboration with development teams

Requirements

• Bachelor's Degree
• 5 years of experience in customer service or complaint handling within the medical device or similarly regulated industry
• Compliance with ISO 13485, FDA QSR, and EU MDR
• Strong coordination, organizational, and project management skills
• Familiarity with CRM systems such as Salesforce, and with ERP and eQMS platforms

Benefits

• Meaningful work in a rapidly growing company with opportunity for advancement
• Directly influence the quality of products and make a difference for patients worldwide
• Opportunities for professional and personal growth
• salary: $85,000-120,000

Sentec offers competitive benefits like Medical, Dental, Vision, HSA, FSA, and 401K matching, as well as paid parental leave, a wellness stipend and tuition reimbursement. Sentec emphasizes employee voices and recognizes hard work making it a promising environment for professional growth. Sentec focuses on delivering impactful healthcare products and improving patient care.

By choosing a career at Sentec, you’re not just choosing a job – you’re embracing the chance to make a real impact, contributing to the development of innovative medical solutions that support the wellbeing of individuals worldwide. 

Sentec is a Swiss-American medical device company specializing in respiratory care. Since its founding in 1999, Sentec utilizes a deep-tech approach that is founded on advanced science and avant-garde technologies for respiratory patients across care areas. Sentec provides healthcare professionals worldwide with non-invasive, continuous monitoring and effective therapeutic solutions.