Your role:

• Works under general supervision and established processes and operational policies with independent judgement, investigates and assists in resolving highly complex complaints by monitoring product analysis findings or service analysis notes and ensures the implementation of solutions to address customer concerns efficiently.
• Leads the implementation of good faith efforts (GFE), diligently reviews, and analyzes supplementary data as required to fortify the investigation process and demonstrates a commitment to thoroughness and accuracy.
• Ensures the application of internal follow-up measures to procure further essential information necessary for reinforcing the investigation process, ensuring thoroughness and accuracy in analysis and decision-making.
• Establishes standards for appropriate coding to records as input for the complaints process, coordinates requests for new coding, when necessary, ensures all systems and tools are updated, and reviews and updates complaints as new codes become available.
• Leads the end-to-end investigation of complaints, including condensing pertinent information, analyzing findings, and presenting a concise overview of the inquiry process, including key issues identified, evidence gathered, and resolutions proposed or implemented.
• Reviews customer response letters (CRL) or internal responses upon concluding the investigation, utilizes effective communication and problem-solving skills, and escalates complex matters to appropriate channels for further assistance and resolution.
• Utilizes analytical skills to resolve medium complexity requests by exercising judgment within established procedures, analyzing complaint data, gathering additional information to assess potential product enhancements, defects, and safety issues.
• Handles moderate to high complexity investigations into post-market complaints and adverse events, ensures thorough and timely resolution by analyzing complaint data and documentation to identify trends, root causes, and potential product issues.
• Develops detailed investigation plans with clear objectives, methodologies, and timelines, conducts root cause analyses to identify underlying issues and documents findings, corrective actions, and preventive measures in comprehensive reports.
• Supports the training and qualification of new PMS complaint operations investigators, provides guidance, resources, and hands-on instruction to facilitate their understanding of complaint handling processes, regulatory requirements, and best practices.

You're the right fit if you have the following skills and experience:

• Bachelor’s Degree or Vocational Education in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or an equivalent field.
• 4 years of experience in Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent with Vocational Education.
• Strong knowledge of Post-Market Surveillance Mechanisms.
• Expertise in Quality Management Systems (QMS) and Quality Specifications.
• Proficiency in Data Analysis & Interpretation for decision-making.
• Familiarity with Regulatory Requirements and compliance standards.
• Ability to prepare and maintain Technical Documentation.
• Skilled in Root Cause Analysis (RCA) and CAPA Methodologies.
• Experience in Complaint Management, Recordkeeping, and Vigilance Reporting.
• Capability to deliver Training on quality and compliance topics.
• Solid Business Acumen to align quality initiatives with organizational goals.
• Strong communication and problem-solving skills.
• Excellent English language skills (written and spoken) are essential.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.