Senior Quality Engineer

Key Responsibilities:

• Lead the development and implementation of robust quality systems for biotech products.
• Ensure full compliance with FDA, ISO 9001, ISO 13485, and GMP regulations.
• Investigate non-conformances and manage CAPA processes, performing root cause analysis and corrective/preventive actions.
• Collaborate closely with R&D, manufacturing, and regulatory teams to integrate quality standards in new product development and ongoing processes.
• Conduct internal and external audits, risk assessments, and lead process validations (IQ, OQ, PQ).
• Drive continuous improvement initiatives across the organization by applying Lean Six Sigma methodologies.
• Provide guidance, leadership, and mentorship to junior quality engineers and cross-functional teams to elevate overall quality standards.

Qualifications:

• Bachelor’s in Engineering, Quality, Life Sciences, or a related field (Master's preferred).
• 5+ years of experience in quality engineering, ideally in biotech or pharmaceutical industries.
• Comprehensive understanding of FDA regulations, ISO standards, GMP, and quality management systems (QMS).
• Proven track record in CAPA management, root cause analysis, and risk management.
• Hands-on experience with process validation (IQ, OQ, PQ) and continuous improvement tools (Lean, Six Sigma).
• Strong communication and leadership skills, with the ability to collaborate across teams and drive results.