Our client based in Parkmore Co Galway are looking to hire a Quality Manager.
This is a permeant onsite role.
The Role:
Reporting to the Senior Quality Manager, you will be responsible leading the quality team, making quality related decisions and providing continuous improvement solutions all underpinned by a strong engineering understanding in a Medical Devices manufacturing environment.
Responsibilities:
1. Compliance: Ensuring the Company meets its Customer, Site Quality, Regulatory and applicable Medical Device requirements (ISO13485, 21CFR Part820) through the effective day-to-day leadership and operational management of the Quality Department
2. QMS : Responsible for all aspects of Quality Management Systems Compliance, Product Quality Assurance and the Risk Management Process
3. CAPA: Maintaining a robust CAPA process to manage nonconformances, potential non-conformances and quality assessments
4. Audits: Managing all aspects of the Company internal and external Audits; responsible for the audit schedule to assure compliance to, and effectiveness of quality systems and policies (includes outsourced processes). Hosting Notified Body, FDA and Customer Audits
5. Quality Culture and Accountability : Driving the culture of quality across the site and within the quality function. Ensuring all employees are accountable and responsible for their own product quality
6. Continuous Improvement : Creating and driving continuous improvements in conjunction with other functions
7. Cross Functional Working : Effectively communicate, support and influence across all levels and functions. Actively support New Product Introduction
8. People Management and Development: Building an effective and high-performing quality department
9. Execution: Proven track record in problem solving, decision-making and execution whilst demonstrating strong interpersonal and relationship building skills. Excellent organisation skills and attention to detail when managing multiple activities
10. Knowledge/Skills in the following areas would be an advantage: 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:
11. 8+ years’ experience with a strong preference for experience in a Medical Device manufacturing and/or SME environment
12. New product introduction and manufacturing process transfer experience would be an advantage
13. Honours degree in Quality, Engineering, Science, or equivalent
14. Honours degree in Mechanical Engineering is a distinct advantage and highly desirable