Overview: Working alongside our client, a leading medical device manufacturer we are experienced Quality Engineer to join their team.
Benefits:
* 27 days annual leave + bank holidays
* Eligible for a 5% performance bonus
* Personal development plans available for career progression
* Salary sacrifice pension scheme
* 3x life insurance cover
* Free refreshments including tea, coffee & fresh fruit
* Free on-site parking
* Free branded workwear
* Well situated next to a train station with good transport links
Remit:
* As a Quality Engineer you will support the Quality Manager and Regulatory Affairs Manager to drive continuous improvement and develop / maintain Quality throughout all stages of the product Lifecycle.
* The successful candidate will be experienced in Quality Assurance systems and processes, and able to demonstrate knowledge and experience of applying Quality Tools and Techniques, ideally within the medical device sector however regulated industry experience will be considered.
Role:
* Support the companies driven Validation / Verification processes to ensure a successful and timely conclusion using the output from the process as the input into the in-process inspection criteria, sample size and frequency, etc.
* Support the Regulatory Affairs Manager to create and maintain product Technical Files in accordance with requirements.
* Maintain and improve the company's Quality Management System and internal processes.
* Lead targeted problem-solving activities to address specific problems as and when they arise during development and in production.
* Lead Change Management activities ensuring robust adherence to all processes and applicable requirements.
* Support adherence to the company’s Internal and Supplier Audit schedules and the implementation of robust actions to address and follow up on any issues raised.
* Act as an ambassador for Quality throughout all levels of the business. Help to ensure requirements are understood and participate in coaching and training activities as required.
* Other various quality-based tasks as directed by the Quality Manager.
Experience Requirements:
* Knowledge of quality systems e.g., ISO9001, ISO13485, MDD/MDR, CFR Part 820 & ISO14971
* Experience of applying Quality Tools and Techniques within a relevant industry – e.g. FMEA, RCA, CAPA, 8D, APQP, 5 Why, MSA, Statistical Analysis (Minitab).
* Excellent communication skills, both written and verbal.
* Strong organisational and time management skills and ability to manage own workload independently.
* Strong attention to detail
Key Words: “Quality Engineer”, “Senior Quality Engineer”, “Quality Manager”, “Senior Quality Technician”, “Medical Device” “injection moulding”, “ISO13485”, “ISO9001”,
FOOTER
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For all UK job positions work seekers must be eligible to work and live in the UK
Sierra 57 Consult –
Technical Engineering & Manufacturing Recruitment Specialist – Plastics, Packaging & Precision Engineering
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