Quality Engineer in Hertford

An exciting opportunity has arisen for an experienced Quality Engineer to join a rapidly growing medical device company based in Hertford. This is not a traditional Quality Systems or CAPA-focused role. Instead, we are seeking an engineering-led Quality professional who understands the complete product lifecycle, from concept and design through to manufacturing, testing, validation, and production release.

Working closely with R&D, Manufacturing Engineering, Operations, and Regulatory Affairs teams, you will play a key role in bringing innovative medical devices from development into successful commercial manufacture. The role requires a strong understanding of design transfer, manufacturing processes, product testing, inspection methodologies, validation activities, and production quality assurance.

The successful candidate will be equally comfortable reviewing engineering drawings and specifications, developing manufacturing documentation, validating production processes, and supporting new product introductions within a regulated medical device environment.

• Support New Product Development (NPD) projects from concept through to commercial manufacture.
• Work closely with Design, R&D, and Manufacturing Engineering teams throughout the product development lifecycle.
• Participate in design reviews and provide input regarding manufacturability, testability, reliability, and product quality.
• Support Design Transfer activities, ensuring products are successfully transitioned from development into production.
• Review engineering drawings, specifications, BOMs, manufacturing instructions, and product requirements.
• Ensure manufacturing and quality requirements are incorporated into product designs from an early stage.
• Assist in developing production processes capable of consistently delivering compliant products at scale.
• Support manufacturing readiness activities for new product launches.
• Develop and implement inspection methods, quality plans, test protocols, and manufacturing procedures.
• Create manufacturing and quality documentation from scratch where required.
• Work with production teams to optimise assembly and manufacturing processes.
• Drive continuous improvement activities focused on process capability, product quality, and manufacturing efficiency.
• Assist with supplier selection and component evaluation activities.
• Develop and execute product testing strategies for new and existing products.
• Establish incoming, in-process, and final inspection methodologies.
• Perform and oversee product inspections against engineering specifications and acceptance criteria.
• Support verification and validation testing activities.
• Analyse test data and provide recommendations for product or process improvements.
• Ensure robust traceability and documentation throughout manufacturing operations.
• Review and approve production records and manufacturing documentation as part of batch release activities.
• Lead or support process validation activities including IQ, OQ, and PQ protocols.
• Develop validation documentation, protocols, reports, and acceptance criteria.
• Support equipment qualification and manufacturing process development.
• Participate in risk assessments, PFMEA activities, and process capability studies.
• Ensure manufacturing processes are capable, repeatable, and suitable for production scale-up.
• Act as the quality and manufacturing interface between Engineering, Operations, Regulatory Affairs, and Supply Chain teams.
• Support technical investigations relating to product performance and manufacturing processes.
• Collaborate with Regulatory Affairs to ensure product and manufacturing compliance requirements are met.
• Contribute to technical decision-making throughout product development and manufacturing phases.

• Previous experience as a Quality Engineer, NPI Engineer, Manufacturing Engineer, Product Quality Engineer, or similar role within the medical device industry.
• Strong understanding of New Product Development (NPD) processes.
• Experience supporting products through the full lifecycle from design and development through to manufacturing and commercial release.
• Experience working with design transfer activities within regulated manufacturing environments.
• Strong understanding of medical device assembly and manufacturing processes.
• Experience developing manufacturing procedures, work instructions, inspection plans, and test methods.
• Experience with incoming, in-process, and final inspection activities.
• Hands-on experience with product testing, validation, and verification activities.
• Experience supporting process validation activities including IQ, OQ, and PQ.
• Ability to interpret engineering drawings, specifications, tolerances, and technical documentation.
• Strong understanding of Design for Manufacture (DFM) and Design for Assembly (DFA) principles.
• Experience working within ISO 13485 regulated environments.

• Engineering-focused mindset with strong technical curiosity.
• Practical and hands-on approach to problem solving.
• Strong attention to detail and commitment to product quality.
• Excellent communication and stakeholder management skills.
• Ability to work effectively across multidisciplinary teams.
• Self-motivated with the ability to manage multiple projects and priorities.
• Comfortable operating within a fast-paced and growing organisation.

• Opportunity to join an innovative and growing medical device business.
• Work on cutting-edge products that directly impact patient outcomes.
• Significant involvement in product development, manufacturing scale-up, and new product launches.
• Collaborative engineering-led culture.
• Competitive contract rate.
• High visibility role with direct impact on company growth and product success.

If you have a strong engineering background within medical devices and enjoy working at the intersection of product development, manufacturing, testing, and quality, we would love to hear from you.