Corporate Complaints Data Analyst

Position Overview:

The Corporate Complaints Data Analyst is responsible and accountable for quality engineering deliverables required within the post-market compliance & surveillance processes. Act as steward for post-market safety and quality, customer requirements/expectations, and regulatory compliance.

Overall responsibility for ensuring technical rigour and compliance with applicable procedures during risk management, complaint, CAPA, and design-relatedprocesses. Serve as liaison between marketing, manufacturing, quality, and R&D to ensure post-market safety and performance are maintained for all product franchises.

A detail-oriented and proactive professional, leading and supporting key activities related to product quality monitoring and post-market surveillance. This role is critical in ensuring compliance with regulatory requirements (including EU MDR Article 88), maintaininghigh standards of product performance, and driving continuous improvement across all Business Units (BUs).

Key Responsibilities:

Trips & Alerts Process Ownership:

• Lead the monthly Trips and Alerts process to monitor product quality through statistical analysis.

• Manage and maintain associated Power BI dashboards and procedures.

• Ensure timely reporting and compliance with internal quality monitoring standards.

• Coordinate with cross-functional teams to ensure consistent execution.

EU MDR Article 88 Trending:

• Oversee the execution of trending activities in alignment with EU MDR Article 88.

• Deploy and maintain procedures and processes to ensure regulatory compliance.

• Coordinate with cross-functional teams to ensure consistent execution.

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.

Quality Management System Documentation (QMSD) :

• Maintain and update QMSD data base relevant to post-market surveillance and product quality.

• Ensure alignment with global and regional regulatory requirements.

Complaints per Million (CPM) Reporting :

• Lead monthly CPM reporting across all Business Units.

• Verify data accuracy and ensure consistent reporting standards.

• Drive improvements in complaint data quality and visibility.

On Market Quality Review Execution:

• Support execution of the process to support post-market surveillance activities such as product investigations, periodic and ad hoc risk reviews, and product monitoring (trending and tracking) across all product franchises.

• Identify and escalate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severity.

Post-Market Surveillance Reports :

• Support the development and execution of Post-Market Surveillance Reports (PMSRs) and

• Periodic Safety Update Reports (PSURs) as required, especially with Trending analysis/Statistical Analysis

• Collaborate with regulatory and clinical teams to ensure completeness and accuracy.

Design and Development:

• Develop understanding of the current risk profile for all products, including reportable product harms and malfunctions

• Provide quality and compliance input to project teams for project decisions and deliverables, especially those related to risk.

• Participate in design control activities and provide input into identifying failure modes and risk assessment for new and existing products while providing expertise in product complaint history and occurrence levels.

Quality Management System:

• Ensure compliance with all Quality Management System requirements and KPIs.

• Support CAPAs, Health Hazard Evaluations (HHE), audits, inspections, and other investigations using standard quality tools (e.g., fishbone diagrams, Pareto analysis, process mapping, control charts and other Minitab statistical analysis tools).

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.

Authority:

• Act as backup to the Corporate Complaints Manager and other Post Market Surveillance peers.

• Author quality records in the D2 Document Management System.

• Author complaints data analysis reports.

Skills & Experience:

• Expert experience in manipulating datasets, and creating intuitive visual reports.

• Advanced skills in Excel and working knowledge of Minitab or similar statistical tools.

• Demonstrated 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.

• Solid communication skills with the ability to clearly present technical data 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 to work independently with minimal supervision when required.

• 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 to partner effectively.

• 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).

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

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.

Principal Contacts & Purpose of Contact:

• Internal – Vigilance Team, Complaint Intake team, Global Site Complaint Engineers, Information Management,Global Quality Management, Site Quality Leads, R&D, Regulatory Affairs, Clinical Affairs, Quality Engineering, and all other functions as required by the role

• External – External Auditors and Inspectors, Regulatory Agencies, and Notified Bodies.

Travel Requirements:

Position may involve travel up to 10% of the time, which may include overseas travel. Most trips will include overnight travel.

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.

Special Factors :

Maintain communication with contacts across several time zones worldwide