Quality Engineer (Medical Devices)

Amber Therapeutics are looking for a Quality Engineer to make a real impact on patients' lives as we develop a closed-loop neuromodulation therapy to treat mixed urinary incontinence. This is a full-time, permanent role based onsite at our newly built facility on the Harwell Science & Innovation Campus, Oxfordshire.

An exciting opportunity to join our growing team, we are looking for an experienced Quality Engineer to play a critical role within the quality team focussing on managing CAPA's, NCR's, device deficiencies and customer complaints, ensuring timely investigation, resolution, root cause analysis and implementation of corrective actions.

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• Lead investigations of quality issues, identify root causes, and implement effective CAPAs
  
• Monitor CAPA effectiveness, ensure timely closure, and maintain compliant documentation
  
• Review, assess, and resolve product and process non-conformances, working cross-functionally with production, engineering, and supply chain teams
  
• Facilitate NCR investigations, track trends, and report metrics to drive continuous improvement
  
• Receive, log, and investigate customer complaints and device deficiencies (reported via clinical trials) in a timely manner
  
• Perform root cause analysis, coordinate responses, and communicate outcomes professionally to stakeholders and customers
  
• Ensure all complaint and deficiency records are accurate, complete, and regulatory compliant
  
• Support internal and external audits, change control, risk assessments, and FMEAs
  
• Develop, revise, and maintain quality procedures and work instructions
  
• Deliver training and guidance on quality processes and tools
  
• Work collaboratively across functions to achieve departmental and site objectives
  
• Maintain compliance with ISO13485 and CFR Part 820
  

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• Relevant degree in engineering, quality or related field and/or relevant experience.
  
• Demonstrable experience in a quality engineering role in a highly regulated environment (healthcare, aerospace, defence)
  
• Strong knowledge of CAPA, NCR, and complaint handling processes
  
• Proficiency in root cause analysis tools (e.g., 5 Whys, Fishbone, Pareto)
  
• Experience with quality management systems (QMS) and document control
  
• An understanding of ISO 13485:2016 MDR, UKCA, and 21 CFR Part 820 requirements is beneficial.
  

With previous experience as a Quality Engineer in manufacturing within a highly regulated environment, the successful candidate should have exceptional attention to detail and strong problem-solving skills. A proactive self-starter, you will have excellent interpersonal and communication skills, and thrive in a fast-paced, multi-disciplinary environment.

Amber Therapeutics is developing a closed-loop neuromodulation therapy able to treat mixed urinary incontinence for the first time and transform the clinical outcome of a very large untreated patient population. Amber's fully implantable PicostimTM System targets the pudendal nerve with a device that can both stimulate and sense physiological responses. The therapy is configurable to the individual's need and able to respond dynamically to different events, adapting as needed between modes of operation. This principle can be used in broader functional disorders of the nervous system that the Company's academic partnerships are exploring.

This is a chance to be part of a ground-breaking team creating life-changing therapies for millions of people globally. You join us at an exciting phase of our development, as we expand the team and accelerate towards our first Pivotal Trial. In addition, we offer a competitive salary commensurate with experience, private healthcare, income protection, life assurance, company pension scheme and 27 days holiday (plus bank holidays).

Amber Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We look forward to hearing from you.