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Chorley, GBR, United Kingdom
Onsite
Job Description Summary
Who We Are & What We DoHow will you make an impact & Requirement
As the IHE (In-House Engineering) ISO 9001 Quality Management Systems (QMS) / Continuous Improvement Lead & Service Engineer, you will play a dual role combining hands-on technical service expertise with ownership of QMS & continuous improvement initiatives across the In-House Engineering (IHE) function.
You will ensure the reliability, compliance, and performance of clinical trial equipment while driving the enhancement of processes, documentation, and operational excellence through ISO 9001 QMS and Resonant Business System (RBS) methodologies. Your work will directly support patient safety, data integrity, and high-quality service delivery across global clinical studies.
Key Responsibilities
Perform installation, commissioning, calibration, preventative maintenance, troubleshooting, and repair of clinical trial equipment
Support a wide range of devices including infusion systems, laboratory equipment, refrigeration units, diagnostic systems, and patient monitoring devices
Deliver advanced technical support and resolve complex issues to minimise downtime and ensure operational continuity
Maintain accurate service records and ensure all work meets regulatory and manufacturer standards
Lead and manage IHE ISO 9001 IHE QMS activities aligned to ISO 9001, including SOPs, Work Instructions (WIs), and Process Flows (PFs)
Own and maintain engineering training records and ensure compliance with QMS requirements
Support internal audits, documentation reviews, and continuous compliance improvements
Manage Non-Conforming Products (NCP) and Discrepant Material Reporting (DMR) processes
Propose and implement improvements to departmental procedures and service standards
Ensure all engineering documentation is accurate, complete, and audit-ready
Lead and support continuous improvement initiatives through Lean / Kaizen principles
Drive waste reduction, process optimisation, and efficiency improvements across IHE operations
Promote and maintain 6S standards across workshops and engineering environments
Support global RBS initiatives in collaboration with the GSM and wider business
Support day-to-day workshop activities, including workflow coordination and shared mailbox management
Lead or facilitate daily stand-ups and contribute to OTIF and performance KPI delivery
Provide technical input into sourcing, product lifecycle management, and equipment evaluation
Coordinate external vendors and subcontractors where required
Support onboarding, training, and development of engineers, trainees, and apprentices
Build and maintain strong relationships with internal teams, suppliers, and customers
Communicate technical and operational updates clearly, including complex or sensitive information
Support cross-functional collaboration across Operations, QA, Sales, and Supply Chain
Deliver a high standard of customer service and represent Resonant’s values in all interactions
We’re looking for a technically strong and process-driven engineering professional who combines hands-on expertise with a passion for quality and continuous improvement. You are confident operating in regulated environments, take ownership of systems and processes, and are proactive in driving improvements.
This role is ideal for someone who enjoys balancing technical delivery with QMS leadership and continuous improvement, while supporting and influencing teams across the business.
Essential skills and experience:
HNC/HND, BTEC or equivalent qualification in Engineering (or equivalent hands-on experience)
Proven experience (5+ years) in technical service, engineering, or equipment maintenance within regulated environments (e.g. healthcare, laboratory, life sciences)
Demonstrated experience in ISO 9001 QMS administration and compliance activities, including SOPs, audits, and documentation control
Strong hands-on experience in installation, maintenance, calibration, troubleshooting, and repair of medical, laboratory, or refrigeration equipment
Experience supporting equipment such as:
Infusion systems (ambulatory, syringe, volumetric pumps)
Laboratory devices (centrifuges, incubators, balances)
Refrigeration and cold-chain systems
Diagnostic and patient monitoring equipment
Strong knowledge of Quality Management Systems (ISO 9001) and experience working within regulated frameworks (e.g. GxP, healthcare standards)
Experience contributing to or leading continuous improvement initiatives (e.g. Lean, Kaizen, process optimisation)
Strong analytical and problem-solving skills, with the ability to assess complex situations and implement effective solutions
Advanced electrical and electronic engineering knowledge, including interpretation of technical schematics and documentation
High attention to detail, particularly in documentation, record keeping, and audit readiness
Strong organisational skills with the ability to manage multiple priorities in a fast-paced environment
Excellent communication and stakeholder engagement skills
Experience using ERP systems, databases, and Microsoft Office tools
Strong awareness of Health, Safety & Environment (HSE) practices
Ability to work independently while also supporting a collaborative team environment
Physically capable of workshop-based work, including lifting equipment up to 25 kg
Commitment to continuous learning and professional development
Desirable (but not essential):
Experience working within clinical trials, pharma, biotech, or life sciences environments
Familiarity with ISO 17025 and/or ISO 13485 standards
Experience supporting infusion pump servicing and planned maintenance programmes
Previous experience in EBME, OEM, or commercial engineering environments
Project management experience or involvement in cross-functional initiatives
Experience leading audits or acting as a QMS or compliance champion
Experience with continuous improvement frameworks and operational excellence programmes
Supervisory or mentoring experience supporting junior engineers
Familiarity with calibration software, digital tools, or asset management systems
At Resonant, we’re more than a leading life sciences company,we’re a global team united by a shared purpose: the uncompromising pursuit of quality to help our customers move science forward.
When you join us, you become part of a growing global community of more than 850 dedicated professionals. In return for your skills, knowledge, and experience, we are committed to helping you thrive, offering access to high-quality learning, development, and career progression opportunities so you can reach your full potential.
This role is based on-site, with a requirement to work from the office for 5 days per week . Please be aware that you should be ideally within commutable distance from the office.
Our competitive reward package includes, following qualifying periods:
Healthcare coverage
Pension scheme
Flexible working options
Associate engagement activities and wellbeing initiatives
Generous annual leave, plus an extra day off to celebrate your birthday
Whether you bring a background in life sciences or proven operational expertise, this is your opportunity to be part of a collaborative, high-performing team making a real difference.
If you’re ready to take the next step in your career and help clients move their life science programmes forward with clarity and purpose—we’d love to hear from you.
Apply now and join Resonant.