Rullion are looking to recruit for the following role:

• Quality Engineer x 3
• Location Sudbury UK
• Fully site based Monday to Friday
• ASAP Start
• 12 months
• Inside IR35
• £23-25.65 per hour PAYE Rates- Umbrella rates can be provided.
• Flexible working hours
• 37.5 hours per week

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.

Job Responsibilities:

• Provide Quality support to the Manufacturing Operations Team
• Support CAPA & Issue Resolution to ensure timely and accurate completion.
• Administer & support the deviation process to ensure timely and accurate completion.
• 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.
• Support the change control process.
• 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.
• Participate in SQDIP meetings, provide accurate and timely reports, and take responsibility for the achievement of target KPI's for the role.
• Actively use business systems such as CATSWEB, CERDAAC, SAP, Documentum & Learn4U.

Requirements

• 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.

EHS

• Ensuring compliance with safety, health and environmental (SHE) legislation.
• 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.

Teamwork

• 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.

Skills and Experience:

• You will be able to manage time effectively and possess a desire to succeed.
• You will have a flexible approach and ability to adapt according to workload.
• You are self-motivated, reliable, and able to work on own initiative.
• You will be an effective team member and able to communicate across functions.
• You will be curious - keen to understand, learn and try new things, and possess excellent written and oral communication skills.

Qualifications:

• 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. xbpsjku
• GDP & GMP (Good Documentation Practices & Good Manufacturing Practices)

If available please send CV and a member of the team will be in touch

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