Quality Engineer
hace 10 días
Sudbury
Just Temps are delighted to be supporting a highly respected and innovative technology company based in the heart of Suffolk, in their search for an experienced Quality Engineer on a 12-month contract. This is a fantastic opportunity to join a forward-thinking organisation where quality is at the core of everything they do. You’ll play a key role in shaping and strengthening the Quality Management System (QMS) while helping to foster a strong culture of continuous improvement across the site. The Role As a Quality Engineer, you will be responsible for maintaining, monitoring, and enhancing key elements of the QMS, while supporting operational teams and driving quality excellence across the business. Key Responsibilities • Provide hands-on quality support to Manufacturing Operations, • Lead and support CAPA and issue resolution activities, • Manage deviations and quality notifications to ensure timely closure, • Support change control processes, • Prepare for and participate in supplier, customer, and regulatory audits, • Conduct internal and supplier audits, • Review, approve, or reject quality documentation, • Deliver training on key QMS processes, • Generate quality metrics, KPIs, and reports, driving improvement initiatives, • Participate in SQDIP meetings and contribute to achieving site targets, • Work with systems such as CATSWEB, CERDAAC, SAP, Documentum & Learn4U Regulatory & Compliance, • Represent the business during customer audits and regulatory inspections, • Ensure compliance with:, • Data Integrity Regulations, • GAMP standards, • 21 CFR Part 11, • Relevant regulatory guidelines Team Collaboration, • Support project teams with the selection, installation, and commissioning of new equipment, • Act as a key quality voice across cross-functional teams About You, • Strong understanding and practical application of Quality Management Systems, • Confident communicator with the ability to work across multiple departments, • Naturally curious, proactive, and keen to drive improvements, • Excellent written and verbal communication skills Skills & Experience, • Minimum 5 years’ experience in a manufacturing environment, • In-depth knowledge of:, • ISO 13485, • 21 CFR 820, • Experience with GDP & GMP standards, • Strong IT skills, including Microsoft Office, • Experience working with quality and business systems (SAP or similar desirable) Why Apply?, • Work with a leading technology company at the forefront of innovation, • Be part of a collaborative and quality-driven culture, • Opportunity to make a real impact on systems and processes Apply today with Just Temps! Just Temps acts as an Employment Business for the supply of temporary staff.