Quality Engineer

Job Title: Quality Engineer

Location: Witney, Oxfordshire

Salary: -40,000 - -57,000 per annum (Depending on experience)

Position Type: 12-Month Contract

Category: Quality Assurance / Medical Devices & Healthcare Manufacturing

About the Role

Are you an experienced Quality Assurance professional looking to advance your career with a leading organisation in life-changing healthcare technology?

We are seeking a Quality Engineer to join our Quality Assurance team based at our manufacturing site in Witney. In this crucial role, you will be responsible for driving the monitoring, compliance, and continuous improvement of the Quality Management System (QMS). You will act as a Subject Matter Expert (SME) for site-level and divisional projects, ensuring that all product development, processing, validation, and manufacturing processes meet strict regulatory standards.

Key Responsibilities:

• QMS Monitoring & Compliance: Oversee the review, approval, and impact assessment of changes or corrections to documentation, processes, or systems.

• Quality Decision Making: Act as a key authority making critical compliance and quality decisions on products during development, validation, manufacturing, and packaging.

• Project Management: Lead and project manage cross-functional team activities using risk management tools to prioritize efforts and meet strict business timelines.

• Cross-Functional Collaboration: Partner closely with internal departments-including R&D, Technical Services, Engineering, Operations, and Regulatory Affairs-to safely achieve project milestones.

• Team Leadership & Development: Directly manage, monitor, and assist day-to-day activities of direct reports, including performance management, training, and supporting staff recruitment.

• Audit Representation: Step up as a Subject Matter Expert (SME) during internal and external quality audits and high-level cross-functional meetings.

What We Are Looking For:

• Regulated Industry Background: Prior experience in the development or manufacture of regulated products (such as medical devices, pharmaceuticals, or healthcare manufacturing).

• Standards Familiarity: A solid understanding and working knowledge of cGMP and/or ISO Quality System requirements (e.g., ISO 13485).

• Leadership Capabilities: Experience with or a strong desire to manage direct reports, mentor team performance, and run training programs.

• Education: Secondary level education including English and Maths (or equivalent qualification). A scientific or engineering background is highly desirable.

• Core Skills: Strong communication skills, cross-functional relationship management, and proficiency using risk management tools.

What''s on Offer?

• Competitive salary ranging between -40,000 to -57,000 based on experience.

• Opportunities for career growth within a state-of-the-art facility.

• A robust site benefits package.

Benefits:

• Onsite parking

• Electric vehicle charging points

• Subsidised canteen

• Free premium coffee facilities

To Apply: Please submit your updated CV highlighting your compliance, validation, or medical device/pharma manufacturing experience.

Randstad Business Support is acting as an Employment Business in relation to this vacancy.

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