Complaints Data Analyst
Remote
Deeside, United Kingdom
Full Time
23-04-2025
Job Specifications
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 around 10,000 colleagues, we provide our products and services in almost 100 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 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com
Our search for better is changing the lives of our customers. It’s changing the careers of our people too – creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to #ForeverCaring as a Post Market Quality Engineer and you won’t either.
The Role:
The Post Market Quality Engineer 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 rigor and compliance to applicable procedures during risk management, complaint, CAPA, and design related
processes. Serve as liaison between marketing, manufacturing, quality, and R&D to ensure post-market safety and performance are maintained for all product franchises.
Key Responsibilities:
Execute and maintain procedures and processes 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.
Execute quality engineering activities for all post market product surveillance including collection, analysis, and evaluation of product safety and performance data, and detection of trends in data that may warrant further action.
Is an expert in creating and generating Dashboards, Graphics, trend Analysis and reports in Excel, Power BI and Minitab to created detailed data analysis and support Post Market Surveillance reports.
Acts as point of contact to execute Complaint analysis Activities across Convatec Business Units – Advanced Wound Care, Continence Care, Infusion Care, and Ostomy Care.
Extract and generate Complaint performance data analysis necessary for generating applicable reports. Coordinate and provide oversight in the analysis of the complaint data.
Support and Execute the Complaint return process as required
Organize and lead reviews with Development, Operations and Manufacturing on emerging quality issues and participate in any resulting corrective actions. Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Identify and escalate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severity.
Timely and accurate presentation of complaint analysis to all stakeholders, while concurrently supporting root cause analysis for any issues identified as required.
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:
Adhere to all requirements of the Quality Management System and its KPIs.
Support investigations arising from CAPA, complaints, Health Hazard Evaluations (HHE), Internal audits, third party inspections, and other business processes by applying typical quality/problem solving tools such as fishbone/cause & effect, Pareto, process mapping, etc.
Other responsibilities:
Overall responsibility for ensuring technical rigor and compliance to 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 site/s and will embrace/drive Convatec core mission, values and priorities.
Support continuous improvement of quality engineering procedures, processes, and tools.
Authority (if applicable):
Act as the backup of the Complaint Manager and other peers in Post Market Surveillance
Approve quality Records in D2 Document Management system.
Author, Review, Approve data analysis reports
Skills & Experience:
Demonstrate company values, work with integrity, and be a supportive team member.
Excellent written and verbal communication skills, with an open, collaborative 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.
Abitlity to navigate government regulations and standards, including Regulation (EU) 2017/745, 21 CFR 820, ISO 13485 and ISO 14971.
Statistical Analysis certification
Strong project and time management skills, ability to work on multiple tasks concurrently with changing priorities.
Proficient with of MS Word, Excel, PowerPoint, power BI and Minitab.
Desirable:
Certifications in Quality Management Systems (e.g. ISO 13485, 9001, lead auditor, ASQ, etc.)
Six Sigma Green Belt/Black Belt certification or equivalent in statistics
Qualifications/Education:
Master’s degree in a technical or scientific field.
5+ years or equivalent experience in quality engineering role in a medical device or life sciences technology driven company
Experience with various phases of the product development lifecycle including concept, design, implementation, verification, and validation activities necessary for product commercialization.
Experience in product and process risk management, manufacturing processes within a medical device company and Experience in post-market surveillance activities (tracking and trending, investigations)
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 i...
About the Company
At Convatec, #ForeverCaring is our promise to patients & healthcare providers, as we deliver pioneering trusted medical solutions to improve the lives we touch. #ForeverConvatec Know more
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