Corporate Complaints Data Analyst

ConvaTec Inc; City Of London; Remote; GBP 45,000 - 65,000; Full time

Job summary

A leading medical device company is seeking a Corporate Complaints Data Analyst responsible for driving quality excellence across compliance and product performance. This remote role entails rigorous data analysis, collaboration with cross-functional teams, and ensuring adherence to regulatory standards. The ideal candidate should have a Master's degree in a technical field and over 5 years of related experience. Strong statistical analysis skills and Six Sigma methodologies are essential.

Qualifications

• 5+ years of experience in quality engineering, data analytics, or post‑market surveillance.
• Experience supporting product development and lifecycle processes in a regulated environment.
• Strong written and verbal communication skills.

Responsibilities

• Drive quality excellence in post-market compliance and product performance monitoring.
• Analyze quality data trends using statistical methods.
• Collaborate with cross-functional teams for quality objectives.

Skills

Statistical Analysis

Six Sigma methodologies

Data Integrity Validation

Communication Skills

Project Management

Education

Master’s degree in a technical or scientific field

Tools

Excel

Minitab

Job description

Corporate Complaints Data Analyst

The Corporate Complaints Data Analyst is responsible for driving quality excellence across post‑market compliance, product performance monitoring, and customer escalation management. This role ensures technical rigour and adherence to regulatory and internal standards throughout complaint handling, risk management, CAPA, and 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.

Key Responsibilities

• 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.
  • 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.
  • Validate data integrity through rigorous checks and ensure compliance with regulatory and internal standards for data accuracy.
  • Translate statistical insights into actionable recommendations for process optimisation and risk mitigation.
• 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.
• 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.
• Product Quality Analysis
  • Conduct ad‑hoc product investigations and data analysis to identify trends or anomalies.
  • Provide actionable insights to support product improvement and risk mitigation.
  • Collaborate with cross‑functional teams to implement data‑driven solutions that enhance product quality and compliance.
  • Monitor effectiveness of corrective and preventive actions (CAPAs) using quantitative metrics and trend analysis.
• Complaint Evaluation Escalations
  • Assess escalated complaints with the committee for severity, regulatory impact, and potential risk to patient safety.
  • Coordinate with cross‑functional teams to ensure timely resolution and compliance.
  • Document findings and communicate outcomes to relevant stakeholders, including regulatory bodies when required.
• 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.
• Customer Escalations
  • Act as the primary point of contact for escalated customer quality concerns, ensuring timely and professional resolution.
  • Investigate root causes and provide clear, evidence‑based responses to customers.
  • Maintain detailed records of escalation handling for audit and continuous improvement purposes.
  • Generate formal letters to summarise investigations and findings, when applicable.
• Infusion Care Customer Escalations
  • Manage escalations, in collaboration with the Corporate Complaints Manager, specific to Infusion Care products and their B2B customers.
  • Liaise with R&D, Clinical Affairs, and others, if necessary, to resolve technical issues impacting patient safety or product performance.
  • Ensure communication aligns with Convatec’s quality standards, agreements and regulatory obligations.
• Audit Preparation and Execution
  • Participate in preparation activities for internal and external audits, ensuring all documentation and processes meet compliance standards.
• Cross‑Functional Collaboration
  • Partner with R&D, Operations, Marketing, Clinical Affairs, Regulatory, and Post Market Surveillance teams to align on quality objectives.
  • Provide expert input during product development, risk management, and CAPA processes, when applicable.
  • Foster a culture of quality and compliance across all functions through proactive engagement and knowledge sharing.
• 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.
  • Demonstrate the highest quality standards, impart knowledge, and increase best practice across sites and embrace Convatec's core mission, values and priorities.
  • Support continuous improvement of quality engineering procedures, processes, and tools.
  • Expert experience in manipulating datasets and creating intuitive visual reports.
  • Six Sigma Green or Black Belt certification, or equivalent experience in statistical analysis.
  • Advanced skills in Excel and Minitab or similar statistical tools.
  • Proven ability to analyze and interpret large volumes of quality data to detect trends.
  • Knowledge of post‑market surveillance, product risk assessment, and complaint handling procedures.
  • Solid communication skills with the ability to clearly present technical data and collaborate cross‑functionally.
  • Familiarity with regulatory standards, including EU MDR, 21 CFR 820, ISO 13485, and ISO 14971.
  • Excellent project and time management skills.
  • Ability to work collaboratively within cross‑functional teams while demonstrating initiative and self‑direction.
  • Strong 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.

Desirable

• Certification in Quality Management Systems (e.g., ISO 13485, ISO 9001, ASQ, Lead Auditor).

Qualifications / Education

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

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