Post Market Complaints Data Analyst

Post Market Complaints Data Analyst

The Post Market Complaints Data Analyst is responsible for driving quality excellence across post‑market compliance and complaints, and medical device product performance monitoring. This role ensures technical rigour and adherence to regulatory and internal standards throughout complaint analysis, risk management, CAPA, and record audit processes. Acting as a key liaison between Quality, R&D, Operations, Marketing, Clinical Affairs, Regulatory, and Post Market Surveillance, the position safeguards product integrity and patient safety, leads activities related to complaint trending analysis and complaint auditing, and supports audit readiness and cross‑functional collaboration.

• Perform systematic reviews of quality records to ensure accuracy, completeness, and compliance with internal procedures and regulatory requirements.
• Identify gaps or inconsistencies in documentation and initiate corrective actions where necessary.
• Maintain audit‑ready documentation and support internal/external audits by providing validated records.

• Utilise a strong background in statistical analysis to create control charts (e.g., u‑chart) and other visualisations to analyse the statistical significance of quality data trends.
• Perform complex statistical analyses on quality and complaint datasets to identify patterns, correlations, and root causes of systemic issues.
• Apply Six Sigma methodologies (DMAIC, process capability analysis) to drive continuous improvement and reduce variability in product performance.
• Translate statistical insights into actionable recommendations for process optimisation and risk mitigation.

• Monitor complaint data to identify emerging trends, recurring issues, and potential systemic risks.
• Participate in the development and maintenance of dashboards or reports to visualise complaint metrics for leadership review.
• Recommend preventive actions and process improvements based on trend analysis.

• Respond promptly to internal and external requests for quality‑related data, ensuring accuracy and timeliness.
• Extract, compile, and present data from multiple sources to support decision‑making and regulatory submissions.
• Collaborate with stakeholders to clarify requirements and deliver tailored reports.

• Ensure technical rigour and compliance with applicable procedures during risk management, complaint, CAPA, and design‑related processes.
• Support R&D, Operations, Marketing, Clinical Affairs, Regulatory, Post Market Surveillance, external customers and equipment suppliers.
• Demonstrate the highest quality standards, impart knowledge, and increase best practice across sites while embracing Convatec's core mission, values and priorities.
• Support continuous improvement of quality engineering procedures, processes, and tools.
• Participate in preparation activities for internal and external audits, ensuring documentation and processes meet compliance standards.

• Advanced knowledge of post‑market surveillance, product risk assessment, and complaint trending with experience at a medical device manufacturer.
• Familiarity with regulatory standards, including EU MDR (Regulation 2017/745), 21 CFR 820, ISO 13485, and ISO 14971, Article 88.
• Advanced knowledge of statistical analysis of post‑market surveillance data, including Nelson Rules and the use of control charts.
• Advanced skills in Excel and Minitab are essential.
• Experience manipulating datasets and creating intuitive visual reports, with the ability to analyse and interpret large volumes of quality data to detect trends.
• Solid communication skills with the ability to clearly present technical data and collaborate cross‑functionally.
• Proven ability to work collaboratively within cross‑functional teams while also demonstrating initiative and self‑direction to work independently with minimal supervision when required.
• Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style.
• Balanced technical understanding of…