This is a fantastic opportunity to play a key role in maintaining and enhancing quality systems within a regulated environment. You'll be at the forefront of ensuring compliance, driving continuous improvement, and supporting product development in a dynamic and collaborative setting.
This is a full time, permanent, onsite role. Monday to Friday on Days.

Your Key Responsibilities

• Maintain and improve quality systems aligned with ISO 13485, ISO 9001, and applicable medical device regulations.
• Develop and revise SOPs and quality documentation.
• Conduct internal audits to ISO 13485 standards.
• Actively participate in customer and regulatory audits.
• Support new product development, including trials, sampling, and production runs.
• Monitor vendor performance, issue non-conformance reports (NCMRs), and implement controls to protect product integrity.
• Report on quality performance metrics and lead change control initiatives.
• Investigate and close validation deviations, non-conformances, and CAPAs.
• Assist in the creation and execution of validation protocols (IQ/OQ/PQ), including data analysis and test scripting.

Who You'll Work With

• Collaborate closely with the Quality Team to share knowledge and uphold standards.
• Liaise with production teams to resolve quality issues and ensure smooth operations.

Decision-Making Scope

• Make informed decisions on product quality issues flagged during production.
• Escalate complex problems to senior quality leadership when necessary.

What You Bring

• Bachelor's degree in Science, Engineering, or a related field.
• Minimum of 3 years' experience as a Quality Engineer in an ISO 13485 regulated environment.
• Certified Internal Auditor to ISO 13485.
• Proven experience in equipment validation and statistical analysis.
• Strong interpersonal skills, attention to detail, and a proactive problem-solving mindset.

Why You'll Love This Role

• Be part of a team that values precision, collaboration, and continuous improvement.
• Gain exposure to a wide range of quality assurance activities in a regulated industry.
• Develop your career in a supportive environment with opportunities for growth and learning.

Click below to apply.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.