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 contactMichelle Mc Inerney. Skills: Quality Operations Manager