Job title:
Quality Engineering Manager
Company
Collins McNicholas
Job description
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:
- 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
- QMS: Responsible for all aspects of Quality Management Systems Compliance, Product Quality Assurance and the Risk Management Process
- CAPA: Maintaining a robust CAPA process to manage nonconformances, potential non-conformances and quality assessments
- 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
- 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
- Continuous Improvement: Creating and driving 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: Building an effective and high-performing quality department
- 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
- 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:
- 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
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.091 706 717
Expected salary
Location
Galway
Job date
Sat, 31 Aug 2024 22:55:06 GMT
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