Kimal is an innovative manufacturer and distributor of customised procedure packs and vascular access devices, supporting clinical departments in more than seventy countries worldwide. Each year, we produce over two million products across a range of specialties including Cardiology, Radiology, Pacing, Laparoscopy, and Cardiac Surgery. Our pioneering central venous catheter technology is helping to reduce patient risk and improve outcomes in hospitals around the globe.
Location: Hybrid Working (Bromsgrove & Remote)
Reporting to: Quality Manager
At Kimal, we believe success is built through collaboration and shared values. Across every role and team, we are guided by our values of Integrity, Positivity, Inclusion and Kindness. These values shape how we work together, support one another, and create an environment where everyone can thrive.
We are seeking a highly organised and detail-focused Product Complaint Handler to join our Quality team. This is an exciting opportunity for someone with experience in quality, complaint handling, post-market surveillance, or vigilance within a regulated environment who wants to play a key role in ensuring product quality, patient safety, and regulatory compliance.
About the Role
You'll manage product complaints from receipt through to closure, ensuring thorough investigations and compliance with regulatory requirements. You'll assess potential risks to patients and users, support vigilance and post-market surveillance activities, and work closely with teams across Quality, Regulatory Affairs, Manufacturing, Supply Chain, and Customer Services.
Your work will play a key role in maintaining product quality, regulatory compliance, and patient safety, while supporting continuous improvement across our products and processes.
What you'll be doing
- Logging and assessing product complaints from customers, distributors, and healthcare professionals.
- Gathering information required to support complaint investigations.
- Working with Quality, Manufacturing, Supply Chain, Regulatory Affairs, and other departments to investigate issues.
- Reviewing complaint information to assess severity, potential patient impact, and regulatory significance.
- Supporting vigilance activities, including identifying potentially reportable incidents and escalating where appropriate.
- Ensuring complaint files are complete, accurate and compliant with internal procedures and regulatory requirements.
- Monitoring complaint trends and recurring issues.
- Supporting CAPA activities and continuous improvement initiatives.
- Producing complaint metrics and reports.
- Supporting audits and inspections when required.
About You
Essential
- Degree qualified, or equivalent experience, in a scientific, engineering, healthcare, quality, or regulatory discipline.
- Experience working within the medical device, pharmaceutical, healthcare, or another regulated industry.
- Previous experience in complaint handling, quality assurance, post-market surveillance, vigilance, or a similar quality-focused role.
- Experience conducting investigations, analysing findings, and maintaining accurate quality records.
- Good understanding of Quality Management Systems (QMS).
- Knowledge of medical device complaint handling requirements and ISO 13485 standards.
- Strong organisational skills with excellent attention to detail.
- Confident communicator with the ability to build effective relationships with customers and internal stakeholders.
- Able to manage competing priorities, work to deadlines, and maintain accuracy under pressure.
- Full UK driving licence.
Nice to Have
- Knowledge of EU Medical Device Regulation (EU MDR) and post-market surveillance requirements.
- Experience managing Field Safety Corrective Actions (FSCAs) and Field Safety Notices (FSNs).
- Experience using an electronic Quality Management System (eQMS).
- Understanding of risk management principles and ISO 14971.
- Training or practical experience in root cause analysis methodologies, such as 5 Whys, Fishbone (Ishikawa), or 8D.
Benefits:
- 25 days annual leave, with the option to buy an extra 2 days.
- Company Pension Contribution
- Life Assurance from day one
- Healthcare Cash Plan
- Employee Assistance Programme for confidential wellbeing support
- Cycle to Work scheme.
- Discounted gym membership
- Retail discounts and exclusive offers through our employee benefits platform
Kimal is an equal opportunities employer, committed to building a diverse, inclusive, and high-performing workforce. We value difference and believe that diverse perspectives help us innovate and deliver outstanding outcomes for patients, clinicians, and healthcare partners.
We are proud to support the Armed Forces Covenant and welcome applications from veterans, reservists, military spouses/partners, and cadet force adult volunteers. We are also a Disability Confident employer, committed to ensuring that our recruitment process is inclusive and accessible to all.
We are committed to providing an inclusive and accessible recruitment process. If you require any reasonable adjustments at any stage, please let us know and we will be happy to support you.
Product Complaint Handler in Bromsgrove employer: Kimal
Kimal is an excellent employer, offering a dynamic work environment where safety and teamwork are paramount. With a focus on employee growth, you will have the chance to enhance your skills through training opportunities, including forklift operations, while enjoying competitive salaries and comprehensive benefits in a thriving medical manufacturing setting.
