Rullion are looking to recruit for the following role:
Quality Engineer x 3
Location Sudbury UK
Fully site based Monday to Friday
End of January 2026/February 2026 start date
6 months initially
Inside IR35
£20-30 Per hour (TBD)
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 environment
- 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)
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.
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