Our client is a global leader in high performance software and innovative hardware products. The QMS Manager, will play a pivotal role in ensuring the effective implementation and maintenance of the Quality Management System (QMS) across the organization. You will be responsible for overseeing all aspects of quality management, including compliance with relevant regulations and standards. This role requires a detail-oriented individual with strong leadership skills and a desire to drive continuous improvement in quality processes.

Key Responsibilities

1.    Develop, implement, and maintain the QMS in accordance with ISO 9001, ISO 13485, UK MDR 2002 & (EU) MDR 2017/745.

2.    Ensure compliance with applicable regulations and standards, including FDA regulations, (EU) 2017/745, UK MDR 2002 and other relevant requirements.

3.    Lead internal audits, support external audits and ensure timely resolution of audit findings and corrective actions. 

4.    Establish and maintain quality policies, procedures, and documentation to support compliance with regulatory requirements. Management of QMS Processes such as NC, CAPA and Change.

5.    Collaborate with cross-functional teams to integrate quality considerations into product development processes. 

6.    Provide training and guidance to employees on quality management principles and regulatory compliance requirements.

7.    Monitor and analyse quality metrics to identify areas for improvement and drive continuous improvement initiatives.

Required Skills, Knowledge and Expertise

·        Bachelor's degree in a relevant field (e.g., Engineering, Quality Management, Regulatory Affairs).

·        Minimum of 2 years of experience in quality management within the medical device industry. Experience with implementing and maintaining Quality Management Systems (QMS) in accordance with ISO standards.

·        Knowledge of ISO Standards including ISO 13485, ISO 9001, ISO 14971, IEC 62304 and EN 60601. 

·        Knowledge of global regulatory requirements applicable to the company's products and services, such as (EU) 2017/745, UK MDR 2002, FDA regulations, etc.

·        Excellent communication and interpersonal skills, with the ability to interact effectively with employees at all levels of the organization.

·        Detail-oriented mindset with a focus on continuous improvement and driving results.