Are you experienced within Quality Compliance manufacturing with a background in Electronics? Do you have experience of electro-mechanical assemblies whilst working to IPC industry standards? If so, we want to hear from you!
Amber Therapeutics are looking for a Quality Inspector to make a real impact on patients' lives as we develop a revolutionary medical device which uses closed-loop neuromodulation therapy to treat mixed urinary incontinence. This is a permanent role based their new site at Harwell Science & Innovation Campus.
The Role
An exciting opportunity to work in a small, dynamic team, you will collaborate with cross-functional teams to ensure the quality assurance and compliance of products, materials, processes and documentation relating to medical device manufacture, goods in inspection, in process inspection and final product testing. A background in electronics and/or electro-mechanical assemblies is essential for this role.
Key Responsibilities:
All aspects of manufacturing quality compliance (e.g. goods in inspection, in process QC checks, final functional testing and analysing the results)
Reviewing batch records, ensuring error-free manufacturing and batch release.
Creating/enhancing tooling descriptions, perform calibrations and ensuring calibration & maintenance log is updated and non-conforming tools removed from the manufacturing environment.
Maintaining manufacturing KPIs, assessing the production process and creating quality checkpoints
Maintain quality system documentation including supplier records, purchase and manufacturing batch information
Support investigation, analysis and closure of relevant NCRs
Working on corrective actions from non-conformances.
Provide technical support and resolve quality issues with suppliers, customers or auditors
Support engineering teams on projects as required
S
kills & Experience
Experience of working to the requirements of electronics industry standards e.g. IPC-A-600, IPC-A-610 and quality management systems such as ISO13485, AS9100 or ISO9001.
Electro-mechanical apprenticeship or similar higher education award in this or an associated area e.g., HNC, HND or Level 3 NVQ in a relevant area or higher desirable.
Experience of electro-mechanical assemblies in medical device, aerospace, or defence sectors required
Experience in visual inspection and excellent eye for detail
Familiar with test/inspection equipment such as oscilloscopes, multimeters and digital callipers.
Experience in Quality Control function such as inspection and measurement required
Experience in highly regulated environment (healthcare, aerospace, defence) is essential
With a background in electronics within a highly regulated environment, the successful candidate should have an exceptional attention to detail and the ability to work successfully both within a team and independently. A proactive self-starter, you will have strong 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 approach leverages the intelligent capability of its next-generation neuromodulation platform, the Picostim-DyNeuMo, to create 'synthetic reflex arcs' that can sense, interpret, adapt and respond to a patient's individual signals thereby restoring normal physiological function. 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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