Graduate Engineer / Quality Engineer

Quality Engineer x 3

~ Fully site based Monday to Friday

~ ASAP Start

~ per hour PAYE Rates- Umbrella rates can be provided.

~ Flexible working hours

~The Quality Operations Engineer will be responsible for maintaining, monitoring, and improving key elements of the Quality Management System (QMS) for the Sudbury Site, developing a culture of Quality by education, mentoring and example.

Provide Quality support to the Manufacturing Operations Team

Administer & support the quality notification process to ensure timely and accurate completion.

Prepare for supplier, customer, regulatory & notified body audits as required.

Conduct internal & supplier quality audits as required.

Prepare, review, and approve or reject quality related documentation.

Provide support for training in key aspects of the Quality Management System.

Generate quality related metrics, reports and KPI's and lead improvement projects and quality initiatives.

Actively use business systems such as CATSWEB, CERDAAC, SAP, Documentum & Learn4U.

Represent the business in customer audits and regulatory inspections to demonstrate that the client has compliant systems.

Maintain compliance with Data Integrity Regulations, GAMP standards, 21 CFR Part 11 and applicable regulatory guidelines.

Driving a safety-first approach maintaining a zero-accident culture, ensure accident prevention and environmental protection regulations of the facility to assure a safe and productive working environment free of any liabilities or defects.

Engaging with project teams to help with selection, installation, and commissioning of new equipment.

Quality Assurance

~ Competent in the principles of and practical use of the Quality Management Systems.

You will have a flexible approach and ability to adapt according to workload.

5 or more years' experience in a medical manufacturing environment or manufacturing envirionment

~ In depth knowledge of Quality Management Systems, ISO 13485, 21 CFR 820

~ IT literate with strong knowledge of Microsoft Office packages. GDP & GMP (Good Documentation Practices & Good Manufacturing Practices)

Rullion celebrates and supports diversity and is committed to ensuring equal opportunities for both employees and applicants.