Quality Assurance Specialist
3 weeks ago
Job Summary:
We are seeking a highly skilled Quality Technician to join our team at Medstrom. As a Quality Technician, you will play a critical role in ensuring the implementation and maintenance of our ISO13485 QMS.
Key Responsibilities:
- Support 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.
- Co-ordinate supplier audits.
- Support risk management activities.
- Monitor quality data for each site.
- Review Device History Records (DHR's).
- 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 rapidly growing company with a unique ownership model. We offer great career opportunities for those who are keen to progress.
Working Hours:
Standard working hours are 37.5 per week, Monday to Friday, approx. 8.30am – 5pm, with flexible hybrid working available once trained.
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