Quality Engineer
Location: Oxfordshire
Job Type: Full time, 40 hours per week
Contract Type: Permanent
Salary: £40,000 - £50,000 per annum
Benefits: Private healthcare, pension, income protection, life assurance, 27 days holiday + bank holidays, equity scheme
Do you have a strong understanding of quality assurance within a manufacturing environment? Have you previously worked within a highly regulated environment (e.g. healthcare, aerospace, defence)? 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 which will eventually be based onsite at Harwell, Oxfordshire, however whilst this new facility is being built, this will require travel on a short-term basis to Welwyn Garden City 2-3 times a week (until early-mid 2025).
The Role
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 by providing quality engineering support across all aspects of the Quality Management System.
Key Responsibilities:
- Work collaboratively with cross-functional teams 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 facility internal audit programme and the hosting of external audits.
- Work towards departmental and facility objectives.
- Support the supplier evaluation and review system and change control process.
- Provide data trending information as required and effectively communicate it across all levels.
- Work with the engineering and development functions in all aspects of validation.
- Provide quality engineering input into the risk management process and design for manufacture process.
- Participate in establishing compliant and effective manufacturing processes and support in calibration, maintenance, and training programmes.
- Create KPIs to drive decision-making and enhance quality, assessing the production process and creating quality checkpoints.
- Review batch records, ensuring error-free manufacturing and batch release, including improving batch record templates.
- Maintain compliance with ISO13485 and CFR Part 820
- Support the implementation and ongoing management of an eQMS.
Essential Skills & Experience
- Relevant engineering or science degree and/or relevant experience.
- Strong understanding of quality assurance and manufacturing processes.
- Experience in CAPA, NC, complaint and change control activities.
- Experience in highly regulated environment (healthcare, aerospace, defence).
- Experience of developing and auditing quality processes, documents, plans etc.
Desirable Skills & Experience
- Previous experience of working with electronic components
- Experience in Quality Control function such as inspection and measurement.
- An understanding of ISO 13485:2016 MDR, UKCA, and 21 CFR Part 820 requirements.
Person Specification
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.
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 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.
You may also have experience in the following: Quality Engineer, Senior Quality Engineer, Quality Manager, ISO9001, Quality Assurance Manager, Senior Compliance, Manufacturing, Engineering, Electrical Engineer, Mechanical Engineer, QA, Quality Assurance, Compliance, Quality Assurance Engineer, Compliance Manager, etc
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