We are partnering with a medical device company in Oxford, based in the Magdalen Centre, Littlemore, developing a culture-free in vitro diagnostics platform for rapid bacterial identification and antimicrobial susceptibility testing direct from whole blood. The technology integrates Raman spectroscopy, spiral microfluidics separation, and machine learning-driven spectral analysis to deliver clinically actionable results in a fraction of the time required by conventional blood cultural workflows.
This is a hands-on, foundational QA role. You will join a small, highly skilled multidisciplinary team and be responsible for designing, implementing, and sustaining an ISO 13485-compliant QMS from an early-stage baseline. You will work directly with engineering, software, clinical, and operations teams to embed quality processes across the product development lifecycle; including design controls, risk management, software validation, and tool qualification.
About the Role
QMS Development & Maintenance
- Conduct a gap analysis of the current QMS against ISO 13485:2016 requirements and define a roadmap to fully implementation
- Evaluate, select, and implement an electronic Quality Management System (eQMS) appropriate for an early-stage IVD company intending to scale at speed
- Author, review, release, and maintain the full suite of ISO 13485-required SOPs and work instructions
- Prepare the organisation for, and act as internal lead during, Notified Body audits, FDA inspections and other audits performed by external parties
Staff Training & Compliance
- Design, implement and deliver role-appropriate QMS training for all staff, ensuring documented competency records within the eQMS.
- Develop and maintain an ongoing training programme as operating procedures are updated or new procedures are introduced.
- Monitor and report on training completion and compliance status to senior leadership.
- Act as the internal subject matter expert and first point of contact for all quality-related questions from staff.
Internal Audit & Continuous Improvement
- Establish and conduct an internal audit programme against ISO 13485 requirements.
- Own end-to-end NC, CAPA, and complaint processes through to effective closure.
- Conduct root cause investigations and monitor CAPA effectiveness.
- Drive CAPA processes and track effectiveness through to closure.
- Report quality KPIs and QMS health metrics to leadership on a regular cadence.
Documentation, Design and Development
- Setup and own the document control system including version control, approval workflows, retention, access controls
- Deliver training and provide support to colleagues for QA and document control activities
- Ensure design and development procedures are ISO:13485 compliant, and that work instructions aligned with current organisational practices. Also ensure records are maintained throughout the product lifecycle.
- Provide QA review and sign-off on design documents, risk assessments, test plans, and verification / validation reports.
- Ensure each product maintains compliance with the Design and Development procedures
Supplier and Quality Management
- Qualify suppliers, maintain a Supplier List, and conduct supplier audits.
- Manage quality agreements and conduct periodic supplier performance reviews.
- Establish product and production control procedures incorporating quality control and release activities in preparation of design transfer of the prototype into product manufacturing
Software, Design and Development Tool Validation
- Lead or provide hands-on QA input into Computer System Validation (CSV) activities for development tools
- Define validation strategies, author Validation Plans, IQ/OQ/PQ protocols, and Validation Reports.
- Maintain a validated state for all quality-critical software tools and ensure re-validation is triggered appropriately on system changes.
About the Candidate
Essential Requirements
- Demonstrable experience (≥5 years) implementing or managing an ISO 13485-compliant QMS within a hardware focussed medical device or IVD environment.
- Strong working knowledge of ISO 13485:2016, ISO 14971, EU IVDR, and FDA 21 CFR Part 820.
- Hands-on experience authoring and releasing operating procedures, work instructions, and quality management records.
- Experience delivering QMS training and building a culture of quality in a small team.
- Practical experience with eQMS platforms – including evaluation, configuration, and rollout.
- Understanding of Computer System Validation (CSV) / software validation principles (IQ / OQ / PQ) with the ability to author and execute validation plans, protocols and reports.
- Ability to operate independently, prioritise in a fast-moving startup environment, and communicate quality concepts clearly to non-QA colleagues.
- Confident integrating into a multidisciplinary team of scientists, engineers, and clinicians; pragmatic in approach, and able to coach colleagues at all levels on quality practices without being prescriptive.
- Problem solver who is open to constructive challenge with a good continuous improvement mindset.
Desirable Requirements
- Experience in an early-stage startup or spin-out environment where QMS infrastructure did not previously exist.
- Experience with IEC 62304 (medical device software lifecycle) and / or IEC 62366 (usability engineering).
- Exposure to engineering tool qualification or laboratory instrument validation.
- Degree in a relevant scientific, engineering, or quality discipline (or equivalent professional experience).
- Lead auditor qualification to ISO 13485:2016.
…