Principal Engineer, Quality Systems

About the role

The Global Operations & Quality team is seeking a Principal Engineer to lead quality system initiatives for cardiovascular medical devices. You will partner with manufacturing, operations, and sales to ensure compliance, drive process improvements, and support patients worldwide.

Key responsibilities

• Maintain compliance of the Quality Management System (QMS) and related processes such as CAPA, NCR, ECR, internal and external audits, and training.
• Plan and execute the annual audit schedule, assign subject‑matter experts, and assess audit findings to set priorities.
• Provide technical guidance on international standards and regulations, leading special projects that design or recommend new systems and procedures.
• Identify and implement business process improvements, updating procedures to enhance efficiency and user experience.
• Act as local process owner for CAPA, NCR, internal auditing, and risk management, offering first‑level support to system users.
• Recommend documentation changes, evaluate effectiveness, and approve recommendations.
• Train, coach, and mentor lower‑level employees on complex quality procedures.

Required profile

• Bachelor’s degree in a scientific field with at least 6 years of relevant experience, or a Master’s degree with 5 years, or a Ph.D. with 2 years.
• Proven experience in quality systems within the medical device or regulated manufacturing environment.
• Strong analytical skills to assess evidence, rank non‑conformances, and drive continuous improvement.

Required skills

• Quality Management System (QMS) implementation and maintenance
• CAPA, NCR, ECR processes
• Internal and external auditing
• Risk management
• Process improvement and documentation control
• Regulatory compliance (e.g., FDA, ISO 13485)

What we offer

• Opportunity to impact patient outcomes globally
• Cross‑functional collaboration with manufacturing and sales teams
• Professional development in the medical‑device industry