Quality Manager
A permanent onsite role based in Parkmore, Co Galway.
The Role:
As a Quality Manager at TN Ireland, you will lead the quality team and make quality-related decisions, providing continuous improvement solutions in a Medical Devices manufacturing environment. Your strong engineering understanding will be essential in this role.
Responsibilities:
* Compliance: Ensure the company meets customer, site quality, regulatory, and applicable medical device requirements (ISO13485, 21CFR Part 820) through effective 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 internal and external audits, ensuring compliance to quality systems and policies (including 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, ensuring all employees are accountable for their product quality.
* Continuous Improvement: Create and drive continuous improvements with other functions.
* Cross Functional Working: Effectively communicate, support, and influence across levels and functions, supporting 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, demonstrating strong interpersonal and relationship-building skills, excellent organization skills, and attention to detail when managing multiple activities.
* Advantageous Knowledge/Skills: Precision Manufacturing; CNC Machining; Metrology; Geometric tolerancing; Cleanrooms & Cleanroom services; Cleaning and passivation; Finishing technologies - blasting, electro polishing; proficient in Minitab (or equivalent) and the full Microsoft Office suite.
Requirements:
* 8+ years' experience, preferably in a Medical Device manufacturing and/or SME environment.
* New product introduction and manufacturing process transfer experience is advantageous.
* Honours degree in Quality, Engineering, Science, or equivalent.
* Honours degree in Mechanical Engineering is highly desirable.