Caragh Precision is a medical device manufacturing company and a leader in the manufacture of precision engineered products for the top global medical device companies. It has over 100 CNC Machining Centres and assists in all stages of the product lifecycle from concept realisation to manufacturing. Based in Parkmore Galway, it specialises in Cardiovascular, Structural Heart and Orthopaedics.
Role Description We are currently recruiting for an experienced Quality Manager based in Parkmore Business Park, Co. Galway. Reporting to the Senior Quality Manager, this role is responsible for 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.
If you want to be a key member of management in a successful and growing Company, have the ability and ambition to further define the quality culture, introduce new initiatives, implement continuous improvements, and have an accelerated career pathway to Senior Management as a member of the Site Management Team – then this role is for you.
Main Duties 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 Education and Experience
• 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
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Parkmore Business Park West
Galway
H91 CH05
Ireland
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