Senior Quality Engineer

About the role

The Senior Quality Engineer will lead the application of statistical techniques and best‑practice validation methods to support new product introductions and continuous improvement of our Quality Management System. You will work closely with development, manufacturing and operations teams to ensure every component and finished product meets or exceeds defined quality standards.

Key responsibilities

• Develop, modify and maintain quality standards for materials, sub‑assemblies and finished products.
• Collaborate with engineering and manufacturing to implement quality standards.
• Approve IQ/OQ/PQ validation protocols and reports.
• Perform risk assessments and lead mitigation activities.
• Design and implement inspection, testing and evaluation procedures for raw materials and finished devices.
• Drive process improvements through non‑conformance and CAPA programs.
• Manage complaints, non‑conformances, returned material investigations and regulatory reporting.
• Lead supplier performance management, including audits and CAPA tracking.
• Conduct internal audits of the quality management system.

Required profile

• Bachelor’s degree in engineering or related field with 5+ years experience, or Master’s degree with 2+ years in a regulated environment.
• Hands‑on experience with ISO 13485‑compliant quality systems.
• Proven ability to lead cross‑functional quality initiatives.

Required skills

• Statistical analysis techniques
• Validation protocols (IQ, OQ, PQ)
• Risk assessment methodologies
• CAPA management
• ISO 13485 compliance
• Quality engineering principles