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.
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