Main Purpose of the Job
The Quality Engineer will support the Quality Manager and Regulatory Affairs Manager to drive continuous improvement and develop / maintain Quality throughout all stages of the product Lifecycle.
Key Duties & Responsibilities
Represent Quality within the Engineering department to ensure customer and regulatory requirements are met prior to transfer to production.
Support the Europlaz / Customer 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.
The Successful Quality Engineer
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. This role would suit an extremely organised and methodical person with a demonstrable Engineering background. Attention to detail when dealing with quality records is extremely important. Experience working with ISO13485, MDD/MDR, CFR Part 820 & ISO14971 would be advantageous. The right candidate will be comfortable communicating with people at all levels within the business, as well as with suppliers and customers.
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.
Ability and desire to be customer facing and attend customer meetings.
Experience of applying Lean Six-Sigma tools and techniques.
Qualified in an engineering or technical discipline.
Working Hours: 40 per week
To apply please complete the form below and upload your CV and Covering Letter.