Quality Complaints & Vigilance Associate
| Posting date: | 23 June 2025 |
|---|---|
| Salary: | £25,000 to £30,000 per year |
| Hours: | Full time |
| Closing date: | 23 July 2025 |
| Location: | YO8 5DD |
| Remote working: | Hybrid - work remotely up to 1 day per week |
| Company: | GBUK Group |
| Job type: | Permanent |
| Job reference: | GBUK/Reg01-25 |
Summary
GBUK Group is a rapidly growing company comprised of award-winning specialist companies that excel in providing enteral feeding, critical care, patient handling and vascular access devices and services. Our primary goal is to enhance patient care through our innovative solutions. With a network of over 1,500 suppliers supporting the NHS, we have established ourselves as a top 20 supplier since our inception in 2008.
Headquartered in Yorkshire, our 80,000 sq. ft. warehouse ensures the distribution of over 600,000 medical devices to healthcare professionals on a daily basis. Our unique blend of distributed, as well as proprietary products, have expanded our reach to over 45 countries worldwide, with the recent establishment of warehouse facilities in Europe.
At GBUK Group, our culture is deeply rooted in our core values of Solution Focused, Collaboration, Innovation, Adaptability, Communication and Integrity. These values drive our commitment to delivering high-quality products and services that positively impact patient care globally.
GBUK Group is committed to globally enhancing patient care by being the leading specialist provider of enteral, critical care and patient handling products and services. Combined with innovative market leading solutions. GBUK Group enables healthcare professionals to treat patients with confidence; safely and efficiently.
The main purpose of the role is to manage and investigate product complaints to ensure patient safety, product quality, and compliance with global regulatory requirements.
Duties will include:
• Receive and log complaints from customers, healthcare providers, sales teams, or regulatory bodies.
• Ensure all relevant complaint information is documented accurately and completely in the complaint management system.
• Assign appropriate complaint classifications (e.g., reportable vs. non-reportable, product defect vs. use error).
• Perform preliminary assessment of the complaint to determine potential product malfunction, patient impact, and regulatory reporting requirements.
• Review complaint trends for possible adverse events or recurring issues & coordinate product return for physical analysis, if required.
• Work closely with suppliers, R&D, or service teams to investigate root cause and review supplier reports and formulate into a 5 why format.
• Assist in tracking and documenting investigation outcomes, corrective actions, or preventive measures.
• Assess whether the complaint meets criteria for regulatory reporting (e.g., UK MHRA, FDA, MDR, EU Vigilance, TGA and other applicable competent authorities).
• Prepare reports to submit to the applicable notified body if a complaint is considered reportable. Prepare and submit regulatory reports within required timelines.
• Track and trend complaint data to identify patterns or potential systemic issues.
• Generate quarterly complaint reports for quality review and annually for management review.
Essential Requirements
• Experience of working within a QMS system preferably within a Medical device company.
Desirable
• Experience/knowledge of reporting incidents to competent authorities.
• Experience in writing root cause investigations.
Key Competencies
• Excellent interpersonal skills, including the ability to work as part of a team and to work with people from across the whole company.
• Good organisation skills and attention to detail.
• Good written and verbal communication skills.
• A can-do attitude with the ability to take initiative and work to deadlines across multiple simultaneous tasks and projects.
• Problem solver
This position offers an excellent opportunity for an individual looking to build a career in this field while contributing positively to our organisation's success.
Equality:
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law
Salary £25,000 to £30,000
Benefits:
• Additional leave
• Bereavement leave
• Company events
• Company pension
• Cycle to work scheme
• Enhanced maternity leave
• Enhanced paternity leave
• Free flu jabs
• Free parking
• Health & wellbeing programme
• On-site parking
• Referral programme
• Sick pay
Headquartered in Yorkshire, our 80,000 sq. ft. warehouse ensures the distribution of over 600,000 medical devices to healthcare professionals on a daily basis. Our unique blend of distributed, as well as proprietary products, have expanded our reach to over 45 countries worldwide, with the recent establishment of warehouse facilities in Europe.
At GBUK Group, our culture is deeply rooted in our core values of Solution Focused, Collaboration, Innovation, Adaptability, Communication and Integrity. These values drive our commitment to delivering high-quality products and services that positively impact patient care globally.
GBUK Group is committed to globally enhancing patient care by being the leading specialist provider of enteral, critical care and patient handling products and services. Combined with innovative market leading solutions. GBUK Group enables healthcare professionals to treat patients with confidence; safely and efficiently.
The main purpose of the role is to manage and investigate product complaints to ensure patient safety, product quality, and compliance with global regulatory requirements.
Duties will include:
• Receive and log complaints from customers, healthcare providers, sales teams, or regulatory bodies.
• Ensure all relevant complaint information is documented accurately and completely in the complaint management system.
• Assign appropriate complaint classifications (e.g., reportable vs. non-reportable, product defect vs. use error).
• Perform preliminary assessment of the complaint to determine potential product malfunction, patient impact, and regulatory reporting requirements.
• Review complaint trends for possible adverse events or recurring issues & coordinate product return for physical analysis, if required.
• Work closely with suppliers, R&D, or service teams to investigate root cause and review supplier reports and formulate into a 5 why format.
• Assist in tracking and documenting investigation outcomes, corrective actions, or preventive measures.
• Assess whether the complaint meets criteria for regulatory reporting (e.g., UK MHRA, FDA, MDR, EU Vigilance, TGA and other applicable competent authorities).
• Prepare reports to submit to the applicable notified body if a complaint is considered reportable. Prepare and submit regulatory reports within required timelines.
• Track and trend complaint data to identify patterns or potential systemic issues.
• Generate quarterly complaint reports for quality review and annually for management review.
Essential Requirements
• Experience of working within a QMS system preferably within a Medical device company.
Desirable
• Experience/knowledge of reporting incidents to competent authorities.
• Experience in writing root cause investigations.
Key Competencies
• Excellent interpersonal skills, including the ability to work as part of a team and to work with people from across the whole company.
• Good organisation skills and attention to detail.
• Good written and verbal communication skills.
• A can-do attitude with the ability to take initiative and work to deadlines across multiple simultaneous tasks and projects.
• Problem solver
This position offers an excellent opportunity for an individual looking to build a career in this field while contributing positively to our organisation's success.
Equality:
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law
Salary £25,000 to £30,000
Benefits:
• Additional leave
• Bereavement leave
• Company events
• Company pension
• Cycle to work scheme
• Enhanced maternity leave
• Enhanced paternity leave
• Free flu jabs
• Free parking
• Health & wellbeing programme
• On-site parking
• Referral programme
• Sick pay