Job Description

Do you have proven experience in supplier quality management & supplier auditing within a highly regulated industry? Looking to make a real impact in a fast-growing medical device company? We want to hear from you!

Amber Therapeutics are looking for a proactive and experienced

Supplier Quality Engineer

in a new role to own our supplier management programme. This is a remote role which involves frequent travel to supplier sites (30-50% both UK & overseas) as well as monthly onsite visits at our new custom-built facility at Harwell, Oxfordshire. Amber is a pioneering neuromodulation company dedicated to transforming the lives of patients through advanced medical technology and quality is at the heart of everything we do.

The Role

You will be accountable for providing quality engineering support across all aspects of our supplier management programme ensuring our suppliers meet the required standards and that quality is embedded at every step. This is a hands-on, high impact and collaborative role which offers you an exciting opportunity to make a difference in a fast-scaling, forward-thinking organisation.

Key Responsibilities:

Driving our supplier evaluation system - onboarding new suppliers, auditing existing ones, managing supplier quality agreements, and owning supplier corrective actions (SCARs). Conducting supplier audits - both remotely and on-site (UK & international). Working directly with R&D and Manufacturing Engineering to select and support new suppliers and drive process improvements. Where required work (temporarily) on site at suppliers to oversee quality of supplier work Contributing Quality Engineering expertise to design-for-manufacture, risk management, and root cause analysis. Supporting our internal audit programme and preparing for external inspections. Handling CAPAs, complaints and non-conformances with clarity and confidence. Reporting key trends and insights to senior leaders. Ensuring compliance with ISO13485 and CFR Part 820.

Skills & Experience

Essential

Relevant Engineering or Science degree and / or relevant experience Demonstrable experience of supplier quality management within a highly regulated environment (e.g. healthcare, aerospace, defence) Proven track record of external supplier auditing Experience of supplier corrective action management Strong understanding of quality assurance and manufacturing processes Experience in CAPA, NC, complaint and change control activities Willingness & flexibility to travel regularly (UK & internationally)


Desirable

Certification as an ISO Lead Auditor is preferred An understanding of ISO 13485:2016 MDR, UKCA, and 21 CFR Part 820 requirements


A clear, confident communicator, with a collaborative and pragmatic mindset, you will have excellent interpersonal skills, and thrive in a fast-paced, multi-disciplinary environment.

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. Please refer to our website for further information.

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. Apply now, and let's make a difference together.