Role Summary
We are seeking an experienced Post Market Complaints Data Analyst to join a global quality team supporting post-market surveillance, product quality monitoring, and regulatory compliance activities. This position plays a critical role in analysing complaints and quality data, identifying trends and risks, and delivering data-driven insights that support product performance, patient safety, and continuous improvement initiatives across a global medical device portfolio. Working closely with Quality, Regulatory, Clinical, R&D, and Operations teams, you will help ensure compliance with industry regulations while driving excellence in quality monitoring and reporting.
Key Responsibilities
- Lead monthly product quality monitoring activities, utilising statistical analysis and trending methodologies to identify emerging quality signals and product performance concerns.
- Develop, maintain, and enhance Power BI dashboards and reporting tools to support quality monitoring and business decision-making.
- Conduct detailed complaint investigations, trend analysis, and ad hoc data reviews to support product improvement and risk mitigation programmes.
- Support post-market surveillance activities, including trending analysis, product monitoring, risk reviews, and safety reporting requirements.
- Ensure compliance with quality management systems, complaint handling processes, and relevant regulatory requirements, including EU MDR trending obligations.
- Partner with cross-functional stakeholders to drive continuous improvement, maintain product quality standards, and support regulatory inspections, audits, and CAPA activities.
Skills, Experience & Qualifications
- Proven experience analysing complex datasets and translating findings into actionable business and quality insights.
- Prior experience working within a Medical Devices company is essential
- Advanced Excel skills with experience using statistical analysis tools such as Minitab and data visualisation platforms such as Power BI.
- Strong understanding of post-market surveillance, complaint handling, quality engineering, and risk management within regulated industries.
- Knowledge of medical device regulations and standards, including EU MDR 2017/745, ISO 13485, ISO 14971, and 21 CFR 820.
- Excellent communication and stakeholder management skills, with the ability to work effectively across global cross-functional teams.
- Degree in a scientific, engineering, technical, or related discipline, with 5+ years of experience in quality engineering, data analytics, post-market surveillance, or a similar regulated environment. Relevant quality or statistical certifications would be advantageous.
Why Join?
This is an excellent opportunity to join a global organisation where your expertise will directly contribute to product quality, regulatory compliance, and patient safety. You will have the opportunity to influence decision-making through data-driven insights, collaborate with international teams, and contribute to the continuous improvement of quality and surveillance processes.