Operations Quality Manager

About the Company

Our client is a global leader in the medical devices industry, dedicated to improving lives through innovative healthcare solutions. With a strong commitment to quality, compliance, and continuous improvement, they strive to deliver the highest standards in product development and manufacturing. Their team is driven by collaboration, expertise, and a shared mission to enhance patient care worldwide.

Role Overview
An exciting opportunity has arisen for a Quality Operations Manager to join a leading medical device manufacturer. This role is pivotal in ensuring compliance with regulatory standards, driving quality improvements, and leading a high-performing team.

Benefits:

• Competitive Salary
• Performance-Based Bonus
• Comprehensive Healthcare Package
• Relocation Assistance
• Visa Sponsorship Available

Key Responsibilities

• Quality Leadership: Act as a key member of the Quality Leadership Team, ensuring compliance with ISO standards and regulatory requirements.
• Team Development: Lead, mentor, and develop the Quality Engineering Team to foster a culture of excellence and continuous improvement.
• Process Improvement: Drive Six Sigma initiatives and collaborate with production teams to enhance efficiency and product quality.
• Regulatory Compliance: Oversee CAPA processes, manage audits, and ensure high-quality documentation to meet industry regulations.
• Quality System Management: Maintain key quality system elements, including non-conformance investigations, incident reporting, and customer complaint handling.
• GMP Compliance: Ensure all production and quality engineering activities adhere to Good Manufacturing Practice (GMP) standards.
• Customer Collaboration: Build and maintain strong relationships with external stakeholders to ensure quality expectations are met.

Requirements

• A third-level qualification in Engineering or a Science discipline; a postgraduate qualification is an advantage.
• Minimum 5+ years’ experience in an ISO 9001/2000 or ISO 13485 environment, ideally within Medical Devices or Pharmaceuticals.
• At least 3 years of supervisory experience with a proven ability to lead and develop teams.
• Strong knowledge of Statistical Process Control (SPC) and Six Sigma methodologies (Green Belt certification preferred).
• Experience managing CAPA systems, technical documentation, and regulatory audits, including FDA requirements.
• Exposure to process validation, sterilization, and cleanroom environments is desirable.
• Excellent problem-solving, analytical, and communication skills.
• Strong IT proficiency and ability to work in cross-functional teams.

Why Join?

• Impactful Work: Play a crucial role in ensuring the highest quality standards for life-enhancing medical devices.
• Collaborative Culture: Be part of a team that values expertise, innovation, and continuous improvement.
• Career Growth: Benefit from professional development opportunities and leadership training.
• Commitment to Excellence: Join an organization dedicated to delivering industry-leading products and solutions.