Our client is based in Parkmore, Co. Galway, seeking a Quality Manager for a permanent onsite role.
The Role:
Reporting to the Senior Quality Manager, you will lead the quality team, make quality-related decisions, and provide continuous improvement solutions, underpinned by a strong engineering understanding in a Medical Devices manufacturing environment.
Key Responsibilities:
* Compliance: Ensure the company meets customer, site quality, regulatory, and applicable medical device requirements (ISO 13485, 21 CFR Part 820) through effective day-to-day leadership and operational management of the Quality Department.
* QMS: Responsible for all aspects of Quality Management Systems Compliance, Product Quality Assurance, and the Risk Management Process.
* CAPA: Maintain a robust CAPA process to manage nonconformances, potential non-conformances, and quality assessments.
* Audits: Manage all aspects of the company's internal and external audits; responsible for the audit schedule to ensure compliance to and effectiveness of quality systems and policies (includes outsourced processes). Host Notified Body, FDA, and Customer Audits.
* Quality Culture and Accountability: Drive the culture of quality across the site and within the quality function. Ensure all employees are accountable and responsible for their own product quality.
* Continuous Improvement: Create and drive continuous improvements in conjunction with other functions.
* Cross Functional Working: Effectively communicate, support, and influence across all levels and functions. Actively support New Product Introduction.
* People Management and Development: Build an effective and high-performing quality department.
* Execution: Proven track record in problem-solving, decision-making, and execution while demonstrating strong interpersonal and relationship-building skills. Excellent organizational skills and attention to detail when managing multiple activities.
Requirements:
* 8+ years' experience with a strong preference for experience in a Medical Device manufacturing and/or SME environment.
* New product introduction and manufacturing process transfer experience would be an advantage.
* Honours degree in Quality, Engineering, Science, or equivalent.
* Honours degree in Mechanical Engineering is a distinct advantage and highly desirable.