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Post market complaints data analyst

London
ConvaTec
Data analyst
Posted: 12 January
Offer description

About Convatec

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit

Position Overview:

The Post Market Complaints Data Analyst is responsible for driving quality excellence across post-market compliance and complaints, medical device 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. The incumbent will lead activities related to complaint evaluation, quality auditing, trending, and escalation management, 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:

Complaint Evaluation Escalations:

1. Assess escalated complaints with the committee for severity, regulatory impact, and potential risk to patient safety.

2. Coordinate with cross-functional teams to ensure timely resolution and compliance.

3. Document findings and communicate outcomes to relevant stakeholders, including regulatory bodies when required.

Complaint Trending and Analysis:

4. Monitor complaint data to identify emerging trends, recurring issues, and potential systemic risks.

5. Participate in the development and maintenance of dashboards or reports to visualise complaint metrics for leadership review.

6. Recommend preventive actions and process improvements based on trend analysis.

Record Quality Reviews and Record Auditing:

7. Perform systematic reviews of quality records to ensure accuracy, completeness, and compliance with internal procedures and regulatory requirements.

8. Identify gaps or inconsistencies in documentation and initiate corrective actions where necessary.

9. Maintain audit-ready documentation and support internal/external audits by providing validated records.

Statistical Analysis of Quality Data:

10. Utilising a strong background in statistical analysis to create control charts ( u-chart) and other statistical visualisations to analyse the statistical significance of quality data trends.

11. Analysis to be completed in tools such as MiniTab.

12. Perform complex statistical analyses on quality and complaint datasets to identify patterns, correlations, and root causes of systemic issues.

13. Apply Six Sigma methodologies (DMAIC, process capability analysis) to drive continuous improvement and reduce variability in product performance.

14. Ensure data integrity through rigorous checks and ensure compliance with regulatory and internal standards for data accuracy.

15. Translate statistical insights into actionable recommendations for process optimization and risk mitigation.

Ad Hoc Data Requests:

16. Respond promptly to internal and external requests for quality-related data, ensuring accuracy and timeliness.

17. Extract, compile, and present data from multiple sources to support decision-making and regulatory submissions.

18. Collaborate with stakeholders to clarify requirements and deliver tailored reports.

Product Quality Analysis:

19. Conduct ad hoc product investigations and data analysis to identify trends or anomalies.

20. Provide actionable insights to support product improvement and risk mitigation.

21. Collaborate with cross-functional teams to implement data-driven solutions that enhance product quality and compliance.

22. Monitor effectiveness of corrective and preventive actions (CAPAs) using quantitative metrics and trend analysis.

Customer Escalations:

23. Act as the primary point of contact for escalated customer quality concerns, ensuring timely and professional resolution.

24. Investigate root causes and provide clear, evidence-based responses to customers.

25. Maintain detailed records of escalation handling for audit and continuous improvement purposes.

26. Generate formal letters to summarise our investigations and findings, when applicable.

Audit Preparation and Execution:

27. Participate in preparation activities for internal and external audits, ensuring all documentation and processes meet compliance standards.

Cross-Functional Collaboration:

28. Partner with R&D, Operations, Marketing, Clinical Affairs, Regulatory, and Post Market Surveillance teams to align on quality objectives.

29. Provide expert input during product development, risk management, and CAPA processes, when applicable.

30. Foster a culture of quality and compliance across all functions through proactive engagement and knowledge sharing.

Other responsibilities:

31. Overall responsibility for ensuring technical rigour and compliance with applicable procedures during risk management, complaint, CAPA, and design-related processes.

32. Support R&D, Operations, Marketing, Clinical Affairs, Regulatory, Post Market Surveillance, external customers and equipment suppliers.

33. 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.

34. Support continuous improvement of quality engineering procedures, processes, and tools.



Skills & Experience:

35. Advanced knowledge of post-market surveillance, product risk assessment, and complaint handling with experience at a Medical Device manufacturer.

36. Familiarity with regulatory standards, including EU MDR (Regulation 2017/745), 21 CFR 820, ISO 13485, and ISO 14971.

37. Experience in manipulating datasets and creating intuitive visual reports.

38. Six Sigma Green or Black Belt certification, or equivalent experience in statistical analysis.

39. Advanced skills in Excel and Minitab or similar statistical tools.

40. Demonstrated ability to analyse and interpret large volumes of quality data to detect trends.

41. Solid communication skills with the ability to clearly present technical data and collaborate cross-functionally.

42. Excellent project and time management skills.

43. Proven ability to work collaboratively within cross-functional teams while also demonstrating initiative and self-direction to work independently with minimal supervision when required.

44. Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style

45. Ability to build and nurture strong and positive relationships with other leaders to partner effectively.

46. Balanced technical understanding of products and processes combined with business and compliance acumen.

47. Statistical Analysis certification

48. Strong project and time management skills, ability to work on multiple tasks concurrently with changing priorities.

Desirable:

49. Certification in Quality Management Systems (, ISO 13485, ISO 9001, ASQ, Lead Auditor).

Qualifications/Education:

50. Master’s degree in a technical or scientific field preferred.

51. 3-5 years of experience in or post-market surveillance, complaints, quality engineering

52. Experience supporting product development, risk management, and lifecycle processes in a regulated environment.



Working Conditions

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

Our transformation will change your career. For good. You’ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you’ll be supported to bring them to life. There’ll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet.

This is stepping outside of your comfort zone.

This is work that’ll move you.

#LI-GM1

#LI-Remote

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at .

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

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