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Cure Talent are delighted to be working with a globally recognised Medical Device manufacturer, specialising in Surgical Products & Instruments, who, due to their continued success have an exciting opportunity for a Senior Quality Assurance & Regulatory Affairs Specialist to join their established team.
As the Senior QARA Specialist, you will play a key role in maintaining and improving the QMS to ensure ongoing compliance with applicable regulations and standards. You will support internal and external audits, document control, and procedural development, working closely with teams across the business to uphold the highest quality and environmental standards
To be successful as the Senior QARA Specialist, you will have extensive experience in Quality Assurance within the Medical Device industry, with a strong understanding of ISO 13485 and regulatory compliance requirements. You will be confident in managing audits, developing QMS processes and advising on regulatory updates.
Responsibilities
- Assist in developing and maintaining Quality and Environmental processes in alignment with regulatory requirements.
- Maintain and update internal and external audit plans to ensure continued compliance.
- Approve and oversee QMS documentation.
- Ensure that QMS policies, procedures, and instructions are documented, implemented and maintained.
- Support in conducting and managing internal and external audits.
- Ensure SOPs are established and adhered to across the business.
Required Experience, Skills & Education
- Proven Quality Assurance Experience within the Medical Device industry.
- Degree in a scientific or engineering discipline.
- Strong knowledge of ISO 13485 and regulatory compliance.
- Experience in managing audits and working with external regulators.
- Proven ability to develop, maintain, and improve QMS documentation and processes.
If you are an experienced Senior QARA Specialist looking for a role where you can make a real impact on quality and compliance, click apply now or contact Kris Holmes to discuss further.
