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Quality Assurance Specialist
2 months ago
About the Role:
As a Quality Technician at Medstrom, you will play a crucial role in ensuring the implementation and maintenance of our ISO13485 Quality Management System (QMS). Your primary responsibility will be to support the development, review, and revision of quality system documentation, including procedures, work instructions, and forms.
Key Responsibilities:
- Support the implementation and maintenance of the ISO13485 QMS, ensuring all processes comply with the standard's requirements.
- Assist in the development, review, and revision of quality system documentation, including procedures, work instructions, and forms.
- Manage and maintain quality records, ensuring accuracy, completeness, and accessibility.
- Conduct internal audits to identify and address potential non-conformances in the QMS.
- Support preparation for external audits by regulatory bodies.
- Analyse quality data and participate in corrective and preventive action (CAPA) activities.
- Stay up-to-date on regulatory requirements for medical devices, including ISO13485 and relevant regional regulations.
- Contribute to continuous improvement initiatives within the QMS.
Additional Responsibilities:
- Manage complaint investigations.
- Coordinate supplier audits.
- Support risk management activities.
- Monitor quality data for each site.
- Review Device History Records (DHRs).
- Facilitate non-conformance audits.
Requirements:
- A strong level of IT literacy with experience of common desktop applications, including Excel and Word.
- Experience working within a QMS environment, ideally in the medical device industry.
- The ability to work in a fast-paced environment with strict deadlines.
- The ability to generate detailed, high-quality documentation.
- The ability to perform and/or manage multiple tasks in parallel.
- Excellent interpersonal skills with the ability to collaborate with others.
- To be detail-orientated and strive for continuous improvement.
About Medstrom:
Medstrom is a company that has grown extensively within the last 5 years and is continuing to grow through our unique ownership model. We offer great career opportunities for those who are keen to progress.
Working Arrangements:
Standard working hours are 37.5 per week, Monday to Friday, approx. 8.30am – 5pm, with flexible hybrid working available once trained.
