Convatec Paddington, England, United Kingdom
About Convatec
Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions. With over 10,000 colleagues, we serve approximately 90 countries and provide products that prevent infection, protect at‑risk skin, improve patient outcomes and reduce care costs. In 2024, revenues exceeded $2 billion and Convatec is a constituent of the FTSE 100 Index (LSE: CTEC).
Position Overview
The Corporate Complaints Data Analyst is responsible for driving quality excellence across post‑market compliance, product performance monitoring, and customer escalation management. The role ensures technical rigor and adherence to regulatory and internal standards throughout complaint handling, risk management, CAPA, and audit processes. Acting as a liaison across Quality, R&D, Operations, Marketing, Clinical Affairs, Regulatory and Post Market Surveillance, the analyst leads activities related to complaint evaluation, quality auditing, trending, and escalation management, supporting audit readiness and cross‑functional collaboration.
Key Responsibilities
Statistical Analysis of Quality Data
- Utilize a strong background in statistical analysis to create control charts (e.g., u‑chart) and other visualisations to assess the significance of quality data trends.
- Analyze data using tools such as Minitab and Power BI.
- Conduct 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 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 summarising 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, applying deep product knowledge and regulatory expertise.
- 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 rigor 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/drive Convatec's core mission, values and priorities.
- Support continuous improvement of quality engineering procedures, processes and tools.
Skills & Experience
- Expertise 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.
- Ability to analyse and interpret large volumes of quality data to detect trends.
- Knowledge of post‑market surveillance, product risk assessment, and complaint handling procedures.
- Strong communication skills with the ability to present technical data clearly and collaborate cross‑functionally.
- Familiarity with regulatory standards, including EU MDR (Regulation 2017/745), 21 CFR 820, ISO 13485 and ISO 14971.
- Excellent project and time‑management skills.
- Proven ability to work collaboratively within cross‑functional teams while also demonstrating initiative and self‑direction.
- Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style.
- Ability to build and nurture strong and positive relationships with other leaders.
- Balanced technical understanding of products and processes combined with business and compliance acumen.
- Statistical Analysis certification.
- 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).
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.
Working Conditions
- This is a remote position; however, office presence may be required or allowed for certain meetings, events or specific business needs.
Beware of scams online or from individuals claiming to represent Convatec
A formal recruitment process is required for all our opportunities prior to any employment offer. This includes an interview confirmed by an official Convatec email address. If you receive a suspicious approach over social media, text, email or phone about recruitment at Convatec, do not disclose any personal information or pay any fees. If you’re unsure, contact us at careers@Convatec.com.
Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means 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.