Quality Assurance Specialist
3 days ago
Your Role:
As a Quality Technician at Medstrom, you will be responsible for ensuring the implementation and maintenance of the ISO13485 Quality Management System (QMS). This involves:
Key Responsibilities:
- Supporting the development, review, and revision of quality system documentation
- Managing and maintaining quality records
- Conducting internal audits to identify potential non-conformances
- Supporting preparation for external audits by regulatory bodies
- Analysing quality data and participating in corrective and preventive action activities
Additionally, you will:
- 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
- Experience working within a QMS environment, ideally in the medical device industry
- The ability to work in a fast-paced environment with strict deadlines
- Excellent interpersonal skills with the ability to collaborate with others
- To be detail-orientated and strive for continuous improvement
Medstrom offers a dynamic and supportive work environment, with opportunities for growth and development. If you are a motivated and organized individual with a passion for quality and regulatory compliance, we encourage you to apply for this exciting opportunity.
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