We are a market leading Medical Device Management Service and due to continued growth, we have an exciting opportunity for a Quality Engineer to join our team based in Swindon.
As our new Quality Engineer, you will be responsible for product release, ensuring validation of the manufacturing process and adherence to the Quality Management System requirements.
You will review customer processing validation protocols and reports in order to ensure compliance with relevant and specific standards. As the Quality Engineer you will initiate corrective actions ensuring all relevant parties are informed, you will then verify the effectiveness of these paying due attention to closure dates and ensure these objectives are achieved within this set time.
*Operation of quality activities for site in order to comply with the relevant standards and accrediting bodies, including but not limited to; document control, control of records, complaints, non-conformances, corrective action, risk and opportunity, purchasing controls, pFMEA and calibration of measurement equipment (40%).
*Measurement of optical and alanine dosimeters, statistical analysis and interpretation of batch data, compilation of batch records and associated documentation to enable batch release of dosimeter products (25%).
*Responsible for management of change control and supporting tasks related to validation and re-validation of manufacturing equipment and processes (15%).
*Responsible for managing outsourced supplier processes and dealing with engineering change control, non-conformances and supplier action requests (5%).
*Working with internal stakeholders on continual improvement, lean initiatives, standardisation, harmonisation and the generation of quality reports as required by the business (10%).
*Provides required preparation and auditing support/leadership for external audits conducted by customers, notified bodies and Regulatory Agencies. Conducts internal and supplier audits. (5%)
*Minimum 3 years’ experience in a quality assurance role.
*Experience of working within a regulated environment (preferably ISO9001).
*Knowledge of ISO13485 desirable.
*Knowledge of ISO11137 desirable.
*Excellent verbal and written communication skills.
*Proficient in use of Microsoft Office applications (Word, Excel and PowerPoint).
Ability to maintain good working relationships with production and quality colleagues at all levels of the business.
*Excellent attention to detail.
*Experienced internal auditor.
*A degree or equivalent qualification in life sciences, engineering (or similar) is desirable depending on experience.
If you have the necessary skills and experience and want to join a company passionate about your progression, click apply now or call (phone number removed) and ask for Kris Holmes.
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Salary: £25000 – £35000/annum Benefits
Job Type: Permanent
Location: Didcot, Oxfordshire
To apply for this job please visit www.cv-library.co.uk.