QA Manager

Burghill

6 months ago

Applications closed

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Cure Talent is delighted to be partnered with a global Medical Device company, specialising in life-saving products, who due to continued growth have an exciting opportunity for a Quality Assurance Manager to join them on a permanent basis.

As their new QA Manager, you will be responsible for leading Quality Assurance, ensuring compliance with ISO 13485, FDA 21 CFR Part 820 and other applicable international regulations. This is a key leadership role, managing the QA team, driving a culture of compliance, and ensuring the effectiveness of the Quality Management System across the full product lifecycle.

To be successful as their new QA Manager, you will have proven experience within Medical Devices, a strong understanding of global quality and regulatory requirements, and the ability to work collaboratively with cross-functional teams to deliver strategic and operational quality objectives.

Key Responsibilities

Lead and develop the QA team, managing performance, training, and mentoring.
Maintain and continually improve the Quality Management System in compliance with ISO 13485, FDA QSR, EU MDR and other applicable standards.
Oversee internal and external audits, including hosting regulatory inspections.
Manage CAPA, NCR, and root cause analysis processes, ensuring timely and effective resolution.
Ensure effective document control, review and approve quality-related documentation.
Support product development projects to ensure quality and regulatory requirements are met from concept to commercialisation.
Monitor quality metrics and KPIs, identifying trends and driving improvement.
Manage supplier quality processes, including audits and performance monitoring.

Experience and Skills Required
5+ years of Quality Assurance experience within the Medical Device sector.
Minimum of 2 years in a managerial or leadership role.
Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820 and EU MDR.
Experience hosting regulatory inspections and leading internal audits.
Proven leadership skills with the ability to influence and drive a culture of compliance.

If you have the skills and experience to excel in this leadership role, please get in touch with Kris Holmes today

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