Kleboe Jardine Ltd
Quality Assurance Specialist
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About the Company
My client is a physician-led healthcare innovation company headquartered in the UK, with a growing operating presence in the US. It provides safety products for patients receiving invasive vascular or surgical treatments and aims to commercialise in UK, EMEA, North America and Asia-Pac.
About the Role
This is a part-time role (1-2 days per week, flexed around audit and filing peaks. The time could also be spread across the working week) reporting to the Principal Design Engineer and carrying limited supervision. The postholder is the Company’s dedicated quality and regulatory resource within a team of six — operating an ISO 13485 quality management system for Class I non-sterile devices, owning the annual audit and recertification cycle, and maintaining CE marking and international registrations. My client makes extensive use of artificial intelligence, and the postholder is expected to utilise these tools when drafting and reviewing documentation to make efficient use of time and enhance output.
Responsibilities
- Operate and maintain the Company’s ISO 13485 quality management system for Class I non-sterile devices, keeping documents, records and processes controlled and audit-ready.
- Own the annual recertification and surveillance audit cycle, acting as principal contact for the certification body and lead auditee, and managing preparation and closure of findings.
- Manage nonconformances, CAPAs, complaints, post-market surveillance and vigilance reporting through to documented closure, with support of engineering team.
- File and manage the CE marking — technical documentation, GSPR evidence and the Declaration of Conformity under the EU MDR self-certification route, alongside UK MDR and UKCA requirements — and act as or coordinate the PRRC.
- Maintain FDA compliance for Class I devices, including establishment registration, device listing and records aligned to 21 CFR 820 / the FDA QMSR.
- Support international market access and country filings, preparing registration dossiers and authorised representative documentation and responding to competent authority queries.
- Work with engineering and supply chain to keep the technical file and design history file current, including risk management, biocompatibility, supplier approvals and traceability.
- Run the internal and supplier audit schedule and management review process, reporting against quality objectives to the Principal Design Engineer.
- Monitor changes to applicable regulations, standards and guidance and assess their impact on the Company’s products and QMS.
- Use the Company’s AI tooling to draft, review and quality-check documentation and audit preparation materials, remaining the accountable reviewer for all released records.
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Qualifications
Degree in an engineering, science, quality or regulatory discipline; membership of a relevant professional body (e.g. RAPS, TOPRA, CQI) desirable.
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Required Skills
- Several years’ medical device QA/RA experience with Class I devices essential, ideally as sole or lead resource operating an ISO 13485 QMS in a small or fast-growth company.
- Internal auditor certification essential, lead auditor certification desirable.
- Working knowledge of EU MDR (including the self-certification route to CE marking), UK MDR and UKCA, and FDA requirements; wider international registration experience desirable.
- Familiarity with applicable product standards (e.g. ISO 14971, ISO 10993, IEC 62366) and with managing external contract design and manufacturing organisations.
- Track record of preparing for and passing external audits; highly self-directed, detail-oriented and confident liaising with certification bodies, regulators, suppliers and advisors.
- Interest in continuous improvement, including the optimisation, tailoring and embedding of artificial intelligence within quality and regulatory workflows.
- Adaptable and pragmatic.
Preferred Skills
- Experience in a fast-paced environment.
- Ability to work independently and as part of a team.
Pay range and compensation package
Compensation details are available upon request.
Equal Opportunity Statement
My client is committed to diversity and inclusivity in the workplace. We encourage applications from all qualified individuals regardless of race, gender, age, sexual orientation, disability, or any other characteristic protected by law.
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