A leading biotechnology company develops, manufactures, and sells products based on a unique and market-leading nanopore-based next generation gene-sequencing (NGS) technology. In addition to offering these technologies for research use only (RUO) applications, the company also markets in vitro diagnostic (IVD) instruments using the same advanced NGS platform. The company develops its own assays and reagents and works in close collaboration with a broad network of third parties to support assay development.
Design and manufacturing are based in Oxford, while the company's products are marketed globally for both RUO and IVD purposes. As a result, its instruments and assays must comply with applicable regulations in all sales territories, requiring submissions to relevant healthcare authorities. To ensure regulatory compliance, the company operates two Quality Management Systems (ISO 13485 & ISO 9001).
About the Role
This role will focus on providing quality assurance support throughout the Design & Development process, with a particular focus on electronic sequencers and software.
Key Responsibilities
- Conduct quality reviews of processes, work instructions, and documents (e.g., requirements, specifications, design outputs, drawings, material specifications, labelling, test plans/protocols, test reports) and other quality records.
- Participate in design reviews and contribute to risk management and production process development.
- Conduct internal audits as required.
- Review and approve all design and development-related processes, documents, and records.
- Support the maintenance of ISO 9001 and ISO 13485 certifications through a variety of quality-related activities.
- Build strong working relationships with manufacturing teams.
- Support and, when necessary, lead internal and external audits (including customer, regulatory, and certification audits).
Qualifications / Education
- HND level qualification or higher in a relevant engineering discipline (e.g., electronics or mechanical engineering).
- Desirable:
- Experience or understanding of software development or control systems.
- Lead auditor qualification.
Experience
Essential:
- At least 10 years of experience in a design quality, test, or general quality role related to electronic products (scientific or medical) within a certified ISO 9001 or ISO 13485 environment.
- Strong knowledge of design control, verification, validation, change control, non-conformance management, CAPA, and statistical techniques.
- Quality assurance experience related to electro-mechanical assemblies, PCBA design/manufacturing, labeling, SMD processes, and collaboration with R&D teams.
- Proven understanding of ISO 13485 (especially Product Realisation), ISO 14971, document control, non-conformity, and CAPA.
- Experience in using data analysis to monitor performance and drive quality system improvements.
Desirable:
- Experience in the IVD or medical device industry is advantageous but not essential; a solid grasp of quality principles and their application in product development is key.
- Familiarity with CE audits or FDA inspections from a manufacturer's perspective.
- Expertise in process validation, traceability of materials and records.
- Knowledge of firmware/software development aligned with IEC62304.
- Experience with injection moulding, overmoulding, and computer-controlled robotic production processes.
- Understanding of process risk management (PFMEA).
Knowledge / Skills / Abilities
- In-depth knowledge of ISO standards (such as ISO 9001 or ISO 13485).
- Demonstrated ability to work with external partners and stakeholders while balancing risk and commercial interests.
- Strong interpersonal and organizational skills, with the ability to influence at a senior level.
- Proven capability to build effective internal and external relationships.
Attitude / Other Requirements
- Adaptable and proactive mindset with experience in fast-paced, agile work environments.
- Goal-oriented, with the ability to develop and implement practical solutions.
- Effective communicator, including the ability to explain complex concepts to non-experts.
- Excellent written and spoken English.
- High attention to detail and strong risk-based prioritization skills.
