Amber Therapeutics
Quality Engineer (Medical Devices)
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Are you a Quality Engineer who enjoys solving complex problems, improving processes and helping deliver high-quality medical devices that make a real difference to patients? Do you have previous experience within a highly regulated manufacturing environment (ideally healthcare)? If so, we want to hear from you!
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 (with some flexibility for hybrid working) at our facility on the Harwell Science & Innovation Campus, Oxfordshire.
The Role
We're looking for a proactive and collaborative Quality Engineer to join our growing Quality team. You'll play a key role in maintaining regulatory compliance, driving continuous improvement and supporting manufacturing, supplier quality and product development activities within an ISO 13485 regulated environment. This is an excellent opportunity to work across the full product lifecycle, working cross-functionally to ensure quality is embedded throughout the business.
Key Responsibilities:
- Lead and support CAPAs, non-conformances, complaints and root cause investigations.
- Maintain and improve the Quality Management System, ensuring compliance with ISO 13485 and applicable regulatory requirements.
- Support internal audits, external regulatory and customer audits, and change control activities.
- Manage supplier quality, including supplier approval, performance monitoring, audits and supplier corrective actions (SCARs).
- Establish and monitor quality metrics and KPIs to drive continuous improvement and informed decision-making.
- Review manufacturing documentation and batch records to support compliant product release.
- Provide Quality Engineering support for risk management, design for manufacture and validation activities.
- Collaborate with Engineering and Manufacturing to develop robust, compliant production processes.
- Support equipment calibration, maintenance and training programmes.
- Analyse quality data, identify trends and implement effective corrective and preventive actions.
- Drive continuous improvement initiatives across manufacturing and quality processes.
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About You
You'll be an organised, analytical and solutions-focused Quality professional who enjoys working collaboratively across multiple teams. With previous experience in a highly regulated manufacturing environment, you will have excellent interpersonal and communication skills, and thrive in a fast-paced, multi-disciplinary environment.
We would like to see:
- Strong understanding of quality assurance and manufacturing processes
- Proven experience in CAPA, NC, complaint and change control activities
- Experience in a Quality Control function such as inspection and measurement
- Experience in a highly regulated environment (healthcare, aerospace, defence); healthcare is strongly desirable
- An understanding of ISO 13485:2016 MDR, UKCA, and 21 CFR Part 820 requirements is advantageous
- Experience of developing and auditing quality processes, documents, plans etc
- Relevant Engineering / Science degree and / or relevant experience is essential
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About Us
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.
What We Offer
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, equity 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.
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