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.