[Hiring] Post Market Complaints Data Analyst @Convatec

Role Description

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 plays a critical role in safeguarding product integrity and patient safety. The incumbent will lead activities related to complaint trending analysis and complaint auditing, while supporting audit readiness and cross-functional collaboration.

A proactive and detail-oriented professional, this role is pivotal in delivering actionable insights while ensuring compliance with global regulatory requirements. The position contributes to continuous improvement initiatives, driving best practices and reinforcing Convatec’s commitment to quality and customer satisfaction across all Business Units.

Key Responsibilities

• Record Quality Reviews and Record Auditing:
  • 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.
• Statistical Analysis of Quality Data:
  • Utilising a strong background in statistical analysis to create control charts (e.g. u-chart) and other statistical visualisations to analyse the statistical significance of quality data trends.
  • Analysis to be completed in MiniTab, this is essential.
  • 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 optimization and risk mitigation.
• Complaint Trending and Analysis:
  • 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.
• Ad Hoc Data Requests:
  • 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.
• Other responsibilities:
  • Overall responsibility for ensuring 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.
  • The job holder will demonstrate the highest quality standards, be able to impart knowledge and increase best practice across sites and will embrace/drive 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 all documentation and processes meet compliance standards.

Qualifications

• Master’s degree in a technical or scientific field preferred.
• 3-5 years of experience in post-market surveillance, complaints, quality engineering.
• Experience supporting product development, risk management, and lifecycle processes in a regulated environment.

Requirements

• 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 with the use of control charts, e.g. u-charts to identify trends.
• Advanced skills in Excel and Minitab are essential.
• Experience in manipulating datasets and creating intuitive visual reports, with the demonstrated 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 products and processes combined with business and compliance acumen.
• Strong project and time management skills, ability to work on multiple tasks concurrently with changing priorities.

Desirable

• Certification in Quality Management Systems (e.g., ISO 13485, ISO 9001, ASQ, Lead Auditor).
• Statistical Analysis certification.
• Six Sigma Green or Black Belt certification.

Working Conditions

This is a remote position, but office presence will be required or allowed for certain meetings, events, or to meet certain business needs.