Cure Talent are delighted to partner with a rapidly growing medical technology company that specialises in the design, development and manufacturing of advanced medical devices. Due to their exceptional continued growth, we have an exciting opportunity for a Quality Engineer to join the team in Abingdon.
As the new Quality Engineer, you will support the Head of Quality in the day-to-day administration of the QMS, ensuring compliance with ISO 13485 and other applicable regulations. Your responsibilities will include managing non-conformance processes, performing root cause analyses, supporting internal audits and aiding in the supplier evaluation and product release processes.
To be successful in this role, you will be a detail-oriented professional with a strong background in Quality Management Systems and a proven ability to work independently or collaboratively. You will have experience in medical devices, excellent communication skills, and a proactive mindset to drive continuous improvement.
Key Responsibilities:
Support the maintenance and administration of the QMS in compliance with ISO 13485 and other regulations. Resolve non-conformances and manage change control processes within target deadlines. Conduct root cause analyses and implement corrective and preventive actions. Approve and manage Standard Operating Procedures and ensure proper document control. Assist with internal audit planning, execution, and reporting. Support training record management and supplier evaluation processes. Release products and ensure compliance with all quality standards. Collaborate with cross-functional teams to maintain quality and compliance. Collect and analyse QMS data to drive continuous improvement initiatives. Skills, Knowledge, and Experience:
Degree in a technical or engineering discipline, or proven experience in a relevant role. Previous experience in quality management systems within Medical Devices. Strong understanding of ISO 13485 and applicable quality system standards. Proficiency in risk management processes and root cause analysis methodologies. High attention to detail and ability to follow procedures accurately. If you have the required skills and experience and are ready to take the next step in your career, please get in touch with Kris Holmes or apply today!
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Support the maintenance and administration of the QMS in compliance with ISO 13485 and other regulations. Resolve non-conformances and manage change control processes within target deadlines. Conduct root cause analyses and implement corrective and preventive actions. Approve and manage Standard Operating Procedures and ensure proper document control. Assist with internal audit planning, execution, and reporting. Support training record management and supplier evaluation processes. Release products and ensure compliance with all quality standards. Collaborate with cross-functional teams to maintain quality and compliance. Collect and analyse QMS data to drive continuous improvement initiatives. Skills, Knowledge, and Experience:
Degree in a technical or engineering discipline, or proven experience in a relevant role. Previous experience in quality management systems within Medical Devices. Strong understanding of ISO 13485 and applicable quality system standards. Proficiency in risk management processes and root cause analysis methodologies. High attention to detail and ability to follow procedures accurately. If you have the required skills and experience and are ready to take the next step in your career, please get in touch with Kris Holmes or apply today!
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