Senior Quality Engineer

About the role

The Senior Quality Engineer will ensure that customer specifications and quality standards are consistently met throughout the manufacturing process of medical components, following Heraeus' quality management system.

Key responsibilities

• Verify compliance with customer specifications and internal quality standards during production.
• Conduct root cause analysis, statistical analysis and apply Statistical Process Control (SPC) to drive continuous improvement.
• Manage non‑conformances, customer complaints, trend analysis, investigations and corrective/preventive actions.
• Support process validation activities and ensure adherence to ISO 13485:2016 and other relevant regulations.
• Collaborate with cross‑functional teams to resolve quality issues and implement robust solutions.

Required profile

• Bachelor’s degree in an engineering discipline or business sciences.
• 8‑10 years of experience in a similar quality role, with at least 5 years in the medical device industry.
• Fluent in spoken and written English and Spanish.
• Strong knowledge of ISO 13485:2016 requirements and applicable regulatory standards.

Required skills

• Root cause analysis
• Statistical analysis
• Statistical Process Control (SPC)
• Non‑conformance handling and complaint escalation
• Trend analysis and corrective/preventive actions
• Six Sigma tools
• Geometric Dimensioning and Tolerancing (GD&T)
• Process validation