Associate Quality EngineerDo you have a strong understanding of quality assurance within a regulated manufacturing environment? Have you worked with an electronic Quality Management System (eQMS)? If so, we want to hear from you!Amber Therapeutics is looking for an Associate 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 which will eventually be based onsite at Harwell, Oxfordshire, however whilst this new facility is being built, this role can be remote or hybrid with visits to the Welwyn Garden City site as required.The RoleAn exciting opportunity to join our growing team in a brand-new role, we are looking for an ambitious and self-motivated individual to provide quality engineering support across all aspects of the Quality Management System. The first 12 months will focus on a project to maintain and fully implement the eQMS, identifying improvement opportunities to utilise the functionality of the eQMS across all processes, with the opportunity to progress your career in quality engineering as you develop your skills and experience. Key Responsibilities:Electronic QMS project implementation:• Maintain current modules within the eQMS: review & editing of existing documents for compliance and ensuring the following of change control and document control process steps.• Implement new modules: collaborate with external eQMS provider in managing the implementation, establishing internal procedures and ensuring accuracy of uploaded legacy data. • Identify and implement improvement opportunities to fully utilise functionality.Ongoing tasks:• Collaboration with other departments to investigate and resolve process and product quality issues deploying appropriate tools to assist root cause analysis.• Conduct and facilitate CAPA, NC and complaint activities & participate in internal audit programme.• Supporting the supplier evaluation and review system & change control processes.• Provide data trending information as required and reporting to all levels.• Participation in the establishment of compliant and effective manufacturing processes.• Support the calibration, maintenance and training programmes.• Maintaining compliance with ISO 13485 and CFR Part 820.• Support ongoing management of eQMS. Essential Skills & Experience• Understanding of an electronic Quality Management System.• Strong understanding of quality assurance and manufacturing processes.• Previous exposure to change control activities. • Experience in a regulated environment (e.g. healthcare, aerospace, defence, automotive).• Relevant Engineering / Science degree and / or relevant experience.• Desirable Skills & Experience• Knowledge of Dot Compliance eQMS platform beneficial.• Experience of auditing quality processes, documents, plans etc.• An understanding of ISO 13485:2016 and 21 CFR Part 820 requirements.• With eQMS experience and quality assurance exposure within a regulated, manufacturing environment, the successful candidate should have exceptional attention to detail and strong problem-solving skills. A proactive self-starter, you will have excellent verbal & written communication skills, and thrive in a fast-paced, multi-disciplinary environment.About UsAmber 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 OfferThis 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. Location: OxfordshireJob Type: Full time, 40 hours per weekContract: Type PermanentSalary: £30,000 - £35,000 per annumBenefits: Private healthcare, pension, income protection, life assurance, 27 days holiday + bank holidays, equity schemeYou may also have experience in the following: Quality Inspector Quality Assurance Manager, QA Manager, Quality Assurance Auditor, QA Auditor, Quality Control Manager, QC Manager, Quality Assurance, Quality Control etc.REF-219 158
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