Quality Consultant
Posted 3 days ago by Quality Endodontic Distributors Ltd
Negotiable
Undetermined
Onsite
Peterborough, England, United Kingdom
Summary: Quality Endodontic Distributors (QED) is seeking an independent consultant with expertise in EN 13485:2016 and UK Medical Device Regulations to support their quality management needs. The role involves approximately two days of on-site work per month, focusing on internal audits, document control, and quality objectives. The consultant should have experience with small to medium-sized businesses and a practical approach to implementing ISO 13485. The position is set to start in January 2026.
Key Responsibilities:
- Performing Internal Audits
- Document Control
- Managing CAPA and Non-Conformance
- Managing Quality Objectives
- Preparing and chairing Management Review
- Providing general quality advice as required
- Attending annual SGS audits
Key Skills:
- Expertise in EN 13485:2016
- Good understanding of UK Medical Device Regulations and EU MDR
- Experience in consulting for small-medium size businesses
- Practical approach to quality management
- Experience in implementing ISO 13485
Salary (Rate): undetermined
City: Peterborough
Country: United Kingdom
Working Arrangements: on-site
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Quality Endodontic Distributors (QED), based in Peterborough, is an independent, family owned business founded in 1989 as a wholesaler selling endodontic products primarily in the UK but also in the EU and further afield. Following the retirement of our current consultant, we are looking to contract with an independent consultant fully conversant in EN 13485:2016 and with a good appreciation of UK Medical Device Regulations and the EU MDR. Our needs approximate to 2 days on-site per month, and responsibilities include performing Internal Audits, Document Control, managing CAPA and Non-Conformance, managing Quality Objectives, preparing and chairing Management Review, general quality advice as required, as well as attending our annual SGS audits. The Consultant must have experience in consulting for small-medium size businesses and therefore a practical approach to quality and the implementation of ISO 13485 for business of our size. Start date January 2026. Please send your CV together with your rate to john.shek@qedendo.com. STRICTLY NO AGENCIES