Quality Manager

Posted 8 days 23 hours ago by Sigmar Recruitment

Permanent
Full Time
I.T. & Communications Jobs
Galway, Galway, Ireland
Job Description
Quality Manager About Your New Employer
  • Innovative Medical Device Company: Join a leading company at the forefront of medical device innovation.
  • Global Impact: Work on products that improve patient outcomes worldwide.
  • Career Growth: Opportunities for professional development and career progression.
About Your New Job
  • Lead and Develop Team: As the Quality Manager, you will lead, develop, and support a team of Quality Engineers and Technicians to achieve departmental and company objectives.
  • Quality Leadership: Provide Quality leadership and technical input across manufacturing and new product introduction projects.
  • QMS Management: Ensure effective operation and continual improvement of the Quality Management System (QMS), including document control, calibration, internal audits, and CAPA/NCR processes.
  • Risk Management: Oversee product and process risk management in compliance with ISO 14971.
  • Supplier Management: Manage supplier approval, qualification, and audits, and address supplier-related non-conformances.
  • Batch Release Oversight: Oversee batch release, product disposition, and related quality decisions.
  • Documentation Guidance: Provide guidance to teams in developing and approving protocols, reports, and change control documentation.
What Skills You Need
  • Educational Background: Degree in Engineering or Science (or equivalent technical discipline).
  • Industry Experience: Minimum 5 years' experience in a Medical Device or Pharmaceutical environment.
  • Leadership Experience: Minimum 2 years' experience in a Senior Quality or supervisory role managing Quality personnel.
  • Regulatory Knowledge: Strong working knowledge of QMS requirements and relevant regulatory standards (ISO 13485, 21 CFR 820, MDR).
  • Cross-Functional Collaboration: Proven ability to work cross-functionally in a regulated, fast-paced environment.
  • Leadership and Communication: Excellent leadership, communication, and problem-solving skills.
  • Continuous Improvement Focus: Self-motivated, with a focus on continuous improvement and team development.
What's on Offer
  • Competitive Salary: Attractive compensation package.
  • Professional Development: Opportunities for training and career advancement.
  • Dynamic Work Environment: Work in a fast-paced, innovative, and collaborative environment.