Our client, a well-known company located in Co. Westmeath, is seeking Quality Manager to join their growing team.
This is a newly created permanent position due to business expansion.
Reporting to the Quality Director, this pivotal role involves leading a team of four, overseeing quality system audits, and ensuring the ongoing maintenance and improvement of the Quality Management System (QMS).
This role would also suit a senior Quality professional with people management experience looking to step into a managerial role.
**This role offers a very attractive salary and benefits package.
Quality Manager responsibilities: Represent the company during audits, regulatory visits, and customer inspections, ensuring all quality-related interactions are professionally managed.
Maintain and enhance the Quality Management System (QMS) in compliance with ISO 13485.
Lead and manage the Quality Assurance and Quality Control teams, driving quality improvements and ensuring efficient task delegation.
Oversee CAPAs, NCRs, and audit processes to ensure compliance and continuous improvement.
Collaborate on product design and development, including testing, validation, and commercialization.
Prepare and manage technical documentation in alignment with regulatory standards and company policies.
Quality Manager Requirements A Level 8 qualification in science, engineering, or manufacturing; a masters or PhD is a plus.
A minimum of 3+ years of leadership experience in Medical Devices/Pharma or chemical manufacturing, including supervisory roles.
Strong knowledge of Quality Management Systems, CAPA, NCR, auditing, and regulatory compliance (e.g., IPEC GMP, ISO 13485).
Familiarity with equipment qualification, process validation, and medical device regulations, along with Six Sigma or Lean methodologies experience.
Skills: Auditing Compliance Quality Assurance Quality Management medical devices