Senior Quality Assurance Specialist
The Senior Quality Assurance Specialist will be a key member of the Quality and Regulatory Affairs team. The role involves collaborating with the VP of Quality and Regulatory Affairs in developing and maintaining a quality system that aligns with international standards, such as ISO 13485:2016 and the quality system regulation 21CFR Part820.
* Developing and implementing effective document control processes to ensure consistency and compliance within the organisation.
* Liaising with technical operations to guarantee high-quality product delivery, adhering to established procedures and regulations.
* Contributing to risk management processes to identify and mitigate risks according to ISO 14971:2019 requirements.
* Representing the quality function at functional team meetings and supporting teams in achieving objectives through advice and documentation reviews.
* Maintaining internal audit systems and ensuring audits are completed on schedule.
* Supporting supplier management programs to meet quality system requirements.
* Developing reports, documents, and specifications to facilitate project success.
* Driving continuous improvement of quality system processes and business performance.
The ideal candidate should hold a Bachelor's degree in Science or Engineering, with at least eight years of experience in quality assurance or regulatory roles, preferably in the medical device industry. Strong communication skills, self-motivation, and ability to prioritise tasks are essential.