Senior Quality Manager
About Your New Employer
- Join a high-tech, high-growth company recognized for its cutting-edge medical device manufacturing technology.
- Be part of a team that has won prestigious awards, including the "Best Overall Business of the Year" and the Innovation in Engineering Award.
- Work with a company that has recently expanded with a new €20 million purpose-built manufacturing and R&D facility, and has tripled its team size since 2021.
About Your New Job
- Drive Quality Compliance: Ensure quality compliance across all departments involved in New Product Introduction (NPI) processes.
- Lead and Develop Reports: Lead and develop direct reports within the regulatory and manufacturing quality teams, specifically supporting NPI projects.
- Resource Management: Ensure that direct reports working on NPI initiatives receive necessary training and resources to execute their responsibilities effectively.
- Implement Quality Systems: Design and implement robust quality systems and procedures tailored to NPI requirements, fully aligned with FDA regulations and ISO standards.
- Champion Quality Representation: Throughout the lifecycle of new product launches and continuous improvements to existing products.
- Address Customer Complaints: Ensure prompt and thorough resolution of customer complaints and queries related to NPI products.
- Collaborate Across Departments: Facilitate the execution of regulatory strategies for new product introductions.
- Assess Regulatory Requirements: For newly developed or modified products within the NPI scope.
- Track and Audit Activities: Ensure complete adherence to applicable regulatory requirements for all NPI projects and track quality-related activities specific to NPI operations onsite.
- Manage Non-Conformance Reports: Initiate and manage non-conformance reports and CAPAs for quality issues arising from NPI, ensuring comprehensive investigations and corrective actions.
What Skills You Need
- Educational Background: Bachelor's degree (level 8 or higher) in quality or a related discipline.
- Proven Experience: Minimum of 3 years of proven people management experience.
- Industry Experience: 10+ years of experience in a regulated industry. Ideally in Medical Device
- Technical Knowledge: Strong knowledge of Quality Management Systems (QMS), FDA regulations, and ISO standards & NPI.
- Leadership Skills: People management experience is essential.
What’s on Offer
- Competitive Salary: €70,000 to €75,000
- Career Development: Opportunities for training, development, and career progression.
- Innovative Environment: Work in a dynamic and collaborative environment with cutting-edge technology and projects.
What’s Next
Apply now by clicking the “Apply Now" button or call Ross Keyes, on 091749269. If the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.
