Excellent opportunity for a QA Supervisor to lead quality systems in a Life Sciences company in the west of Ireland.
About Your Responsibilities
* Develop and document a Quality System compliant with I.S. EN ISO 13485, EC Directive (93/42/EEC), and global/local quality policies.
* Create procedures and plans to meet regulatory, business, and customer needs.
* Educate and ensure relevant staff understand, implement, maintain, and access quality procedures.
* Coordinate with Quality Assurance and regulatory bodies.
* Conduct quality system audits as needed.
* Ensure products meet regulatory and customer standards.
* Track and report Quality System performance through metrics for management reviews.
* Monitor quality performance and advise management on critical issues.
* Inform management of system failures and ensure corrective actions are taken.
* Oversee and train quality personnel.
Knowledge, Skills, and Experience Required
* Diploma or degree in Quality, Engineering, or Business-related disciplines.
* Minimum 6 years of relevant experience, with at least 2 years in a regulated manufacturing setting.
* Experience in team management is advantageous.
* Familiarity with ISO 13485 or ISO 9000 standards.
* Strong communication and team-building abilities.
* Ability to adapt quickly to team environments.
* Flexible approach to tasks.
* Understanding of Medical Device Regulations.