- 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 global regulatory requirements applicable to the company's products and services, such as (EU) 2017/745, UK MDR 2002, FDA regulations, etc.
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Quality and Systems Manager - Oxford, Oxfordshire, United Kingdom - Energy Jobline CVL
Description
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.
Establish and maintain quality policies, procedures, and documentation to support compliance with regulatory requirements. Management of QMS Processes such as NC, CAPA and Change.Collaborate with cross-functional teams to integrate quality considerations into product development processes.
Provide training and guidance to employees on quality management principles and regulatory compliance requirements.
Monitor and analyse quality metrics to identify areas for improvement and drive continuous improvement initiatives.
Bachelor's degree in a relevant field (e.g., Engineering, Quality Management, Regulatory Affairs).