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An exciting opportunity has arisen for a Quality Manager in the medical device sector, specifically focusing on overseeing and ensuring the quality management systems are compliant with regulatory standards.

Client Details

My client is a leading manufacturer in the medical device sector, they are looking for a Quality Manager to oversee and ensure the quality management systems (QMS) are compliant with regulatory standards. The role involves driving continuous improvement, maintaining certifications, and managing audits to ensure the highest standards of product quality.

Description

As the Quality Manager you will be responsible for:

Lead the implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and other relevant standards.
Ensure regulatory compliance for medical devices, managing all audits and certification processes.
Oversee quality control procedures across all production stages, ensuring defect-free products.
Manage the internal audit program and support external audits by regulatory bodies and customers.
Investigate quality issues and implement corrective and preventive actions (CAPA) to address root causes.
Collaborate with cross-functional teams to drive continuous improvement initiatives in manufacturing processes.
Monitor supplier performance, conducting audits and assessments to ensure they meet quality standards.
Train and develop staff on quality procedures, regulatory requirements, and best practices.Profile

A successful Quality Manager should have:

Bachelor's degree in engineering, life sciences, or a related field.
Demonstrable experience in a quality management role, ideally within the medical device or healthcare industry.
Strong knowledge of ISO 13485 and other relevant quality standards and regulations.
Experience in leading internal and external audits, with a track record of maintaining regulatory compliance.
Excellent problem-solving skills, with experience in root cause analysis and CAPA processes.
Ability to manage cross-functional teams and industry-related continuous improvement projects.
Strong communication and interpersonal skills for collaborating with internal and external stakeholders.
Detail-oriented, with a commitment to maintaining high standards of product quality and safety.sJob Offer

A competitive salary in the range
Comprehensive benefits package including pension and healthcare
Opportunity to work in a leading company in the Life Science industry
Supportive and collaborative working environment
Excellent career advancement opportunitiesIf you're looking to take the next step in your career as a Quality Manager in Swansea, we encourage you to apply today