Quality Compliance Officer

Location: Welwyn Garden City
Job Type: Full time, 40 hours per week
Contract Type: Permanent
Salary: £28,000 - £30,000 per annum
Benefits: Private healthcare, income protection, life assurance, company pension scheme & 27 days holiday

Closing date: 01-04-2024

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 Compliance Officer to make a real impact on patients’ lives as we develop a closed-loop neuromodulation therapy to treat mixed urinary incontinence. This is a permanent role based in Welwyn Garden City, although will be moving in 12-18 months to new premises in either the Bristol or Oxford area.

The Role

An exciting new role within our growing 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.

Skills & 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.
• Experience in highly regulated environment (healthcare, aerospace, defence)
• 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.

We look forward to hearing from you!

You may also have experience in the following: Quality Assurance Manager, QA Manager, Quality Assurance Auditor, QA Auditor, Quality Control Manager, QC Manager, Quality Assurance, Quality Control etc.

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