Quality Manager

Job Summary

The Quality Manager provides strategic and operational leadership for the Quality Assurance and Quality Systems functions. Accountable for maintaining an effective Quality Management System (QMS), ensuring regulatory compliance, delivering quality objectives, managing departmental budgets, driving continuous improvement, and developing a high-performing organization. Serves as a key member of the site leadership team and interfaces with executive leadership including Vice Presidents and Senior Vice Presidents of Quality.

Principal Duties and Responsibilities

• Develop and deploy site quality strategy aligned to corporate objectives.
• Set and manage departmental budgets and resource planning.
• Lead Quality Assurance and Quality Systems teams to achieve business and compliance objectives.
• Drive strategic projects including cost reduction, compliance improvement, operational excellence, and Best-in-Class quality initiatives.
• Lead Management Review and quality performance reviews.
• Provide executive reporting to VP Quality, SVP Quality, and site leadership.
• Drive resolution of significant quality, compliance, and business issues.
• Lead regulatory inspections, external audits, and corporate assessments.
• Monitor quality metrics and drive sustained improvement.
• Partner with Operations, Engineering, Supply Chain, and Regulatory functions.
• Educate operational leaders and managers on QMS requirements and quality culture.
• Build organizational capability through coaching, succession planning, and talent development.
• Promote employee engagement, accountability, and continuous improvement

Expected Areas of Competence

• Strategic leadership and business planning.
• Financial management and budget control.
• Expert knowledge of global medical device regulations and standards.
• Strong executive communication and influencing skills.
• People leadership, coaching, and team development.
• Cross-functional collaboration and change leadership.

Education/ Experience Requirements

Bachelor degree in Engineering, Science, Quality or related discipline. Minimum 8 years progressive quality leadership experience in a highly regulated environment.

Travel Requirements

• Up to 15-20% travel as required.
• Travel may include participation in corporate quality reviews, leadership meetings, supplier visits, regulatory inspections, audit activities, training, benchmarking events, and support of strategic business initiatives.
• Occasional international travel may be required to support corporate quality objectives and cross-site collaboration