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Quality System Engineer
2 months ago
We are seeking a dedicated and detail-oriented Quality Systems Engineer to join our client, and ensure their products meet the highest standards of quality and safety. The ideal candidate will play a crucial role in maintaining and improving quality management systems, ensuring compliance with regulatory requirements, and supporting continuous improvement initiatives.
Key Responsibilities for the Quality Systems Engineer:
- Quality Management System (QMS): Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 and FDA regulations.
- Regulatory Compliance: Ensure all processes adhere to applicable regulatory requirements, including FDA, ISO, and other relevant standards.
- Audits: Prepare for and participate in internal and external audits, including those conducted by regulatory bodies and customers.
- Process Improvement: Identify areas for improvement within the QMS and implement corrective and preventive actions (CAPA).
- Document Control: Oversee document control processes, ensuring all quality-related documentation is accurate, up-to-date, and compliant with regulatory standards.
- Risk Management: Conduct risk assessments and develop risk management strategies to mitigate potential quality issues.
In order to qualify for the Quality Systems Engineer role you will need:
- Proven training and experience in auditing to the ISO13485 standard.
- Excellent problem-solving skills and attention to detail.
- Experience with QMS software and document control systems.
- Proficient communication skills, both written and verbal.
- Minimum of 2 years of experience in quality systems engineering,
Please be advised that individuals without the aforementioned qualifications will not be considered for this Quality Systems Engineer opportunity.
If the job role of the Quality Systems Engineer sounds like it suits you, please click apply now
If you would like to hear more information about the Quality Systems Engineer opportunity, please contact Jemma at Orion in Reading.
Due to the volume of applications we receive, unfortunately, we are not able to respond to every application personally, therefore, if you have not heard back from us within 5 working days please assume your application has been unsuccessful. To see our other available vacancies please visit our website.
