Our client, one of Galway's leading SME's are looking to hire a Senior Quality Manager as they continue to expand their operations. The Senior Quality Manager is an exciting opportunity to lead the quality team supporting the Design and Manufacture of a range of Neurovascular devices in an exciting and fast-growing company. This role will also assume ownership of the ISO 13485 / 21CFR 820 compliant Quality Management system. The Senior Quality Manager will lead the transition of the company from a start-up R&D phase to a commercial entity selling Neurovascular products into a multiple of worldwide markets.
- Provide overall leadership to the team and foster a diverse, entrepreneurial environment that enable all participants to contribute to their fullest potential in pursuit of organizational goals and objectives
- Provide quality leadership for product development teams delivering next generation products to the market
- Guide, coach, recruit, and develop organizational talent
- Monitor and ensure compliance with company policies and procedures through the implementation of a robust quality system and communication/reporting to regulatory authorities in conjunction with the Regulatory Group.
- Work in partnership with R&D to support design enhancements for existing products
- Ensure product safety, reliability, and quality through the effective use of planning, risk assessment, statistical methods, and process control during the design and manufacturing stages of the product life cycle
- Ensure continuous improvement in product performance by incorporating learnings into new product development
- Employ lean methodologies to improve the efficiency of the quality system
- Provide direction to project teams and engineers in the processing and development of protocols, reports, procedures, deviations and change requests on a day-to-day basis for identified projects
Skills, Qualifications & Experience
- A graduate of Engineering/Sciences with Minimum 8 years’ experience in a pharmaceutical/Medical Device environment
- Minimum of 5 years of people management experience
- Extensive knowledge of quality management systems and current international and European regulations/standards with respect to medical devices.
- Design for Manufacturing and Six Sigma experience is a plus.
- Excellent interpersonal and communication skills with good leadership abilities; high level of self-motivation
- Demonstrable ability to work in a multi-disciplinary, regulated environment
- The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
For a confidential discussion and further information on the role please contact Amy Newell