
Senior Supervisor, Design Quality Assurance
- Co Galway
- Permanent
- Full-time
- Innovative Environment: Join a leading company in the medical device industry, known for its commitment to patient safety and product quality.
- Diverse Product Portfolio: Work with a wide range of products, including drug eluting therapies, balloon dilatation catheters, and cutting balloons for Interventional Cardiology.
- Career Growth: Be part of a team that values continuous improvement and professional development.
- Lead Projects: As the Senior Supervisor, Design Quality Assurance, you will lead projects related to the balloon catheter product family, ensuring compliance with all design changes and regulatory requirements.
- Supervision and Mentoring: Provide coaching and mentoring support to a team of at least 3 engineers, overseeing small to medium projects within the sustaining organization.
- Quality Leadership: Demonstrate commitment to quality by executing sound quality practices, maintaining an effective quality system, and resolving PIRs, CAPAs, NCEPs, and regulatory requirement changes.
- Cross-Functional Collaboration: Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations teams to provide technical and quality systems input.
- Regulatory Compliance: Ensure and maintain compliance with appropriate guidance documents, such as company SOP/WI's and EU/FDA/Global guidelines.
- Educational Background: NFQ Level 8 qualification in a STEM discipline.
- Experience: Minimum of 6 years of industry experience, preferably in Design Assurance.
- Technical Expertise: Experience in design control, risk management, design change, and standards compliance to regulatory requirements.
- Leadership and Problem-Solving: Strong leadership, problem-solving, technical capabilities, communication, and collaboration skills.
- Team Player: Proven ability to work well both as part of a team and individually, with enthusiasm and motivation to develop your career and drive improvements in product and process quality.
- Competitive Salary: Attractive compensation package.
- Professional Development: Opportunities for training, development, and career advancement.
- Dynamic Work Environment: Be part of a collaborative and innovative team dedicated to excellence in the medical device industry.
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