Quality Engineer

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.
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