Principal Quality Engineer

About the role

The Principal Quality Engineer will lead quality assurance activities for medical device products and processes, ensuring compliance with industry standards and regulatory requirements. This senior position oversees risk management, validation, and continuous improvement initiatives across the site.

Key responsibilities

• Supervise a team of Quality Engineers to meet engineering objectives.
• Identify, develop, and implement continuous‑improvement projects for quality controls, products, and processes.
• Plan and manage tasks related to risk management, change control, and product/process validation for existing, transferred, and new products.
• Support complaint investigations, root‑cause analysis, and corrective actions to enhance customer satisfaction and product safety.
• Maintain the Site Master Validation Plan and ensure compliance during internal and external audits.
• Lead CAPA events and support audit processes and site‑wide continuous improvement plans.

Required profile

• Minimum 5 years of manufacturing quality/engineering experience in a medical‑device environment (ISO 13485, ISO 14971).
• Strong knowledge of process validation and computer‑system validation.
• Project‑management experience, preferably with formal methodologies.
• At least 3 years of experience supervising, coaching, or mentoring engineering staff.
• Proficiency in data analysis and statistical tools.
• Excellent interpersonal and communication skills.

Required skills

• ISO 13485:2003 compliance
• ISO 14971:2019 risk management
• Process validation
• Computer System Validation (CSV)
• Project Management
• pFMEA, Hazard Analysis, Risk Assessments
• Statistical analysis software
• Lean and Six Sigma methodologies