Quality Engineer

The Quality Engineer is responsible for ensuring that products and processes meet established quality standards and regulatory requirements. This role involves developing and implementing quality control systems, conducting root cause analysis, and driving continuous improvement initiatives to enhance product reliability and customer satisfaction.

Key Responsibilities:

• Develop, implement, and maintain quality assurance protocols and procedures.
• Conduct inspections, audits, and testing of products and processes to ensure compliance with internal and external standards (e.g., ISO 13485, FDA, GMP).
• Lead root cause analysis and corrective/preventive action (CAPA) activities.
• Collaborate with cross-functional teams (Engineering, Manufacturing, Regulatory) to resolve quality issues.
• Analyze quality data and metrics to identify trends and drive improvements.
• Support validation and verification activities for new products and processes.
• Participate in supplier quality management, including audits and performance evaluations.
• Maintain documentation and records in accordance with regulatory and company requirements.
• Train staff on quality standards and procedures.

• Bachelor’s degree in Engineering, Quality Assurance, or related field.
• 3+ years of experience in a quality engineering role, preferably in a regulated industry.
• Knowledge of quality tools and methodologies (e.g., Six Sigma, Lean, FMEA, SPC).
• Familiarity with regulatory standards (ISO 9001, ISO 13485, FDA QSR).
• Strong analytical, problem-solving, and communication skills.
• Proficiency in quality software and data analysis tools.

Preferred Certifications:

• Certified Quality Engineer (CQE)
• Six Sigma Green Belt or higher
• ASQ or equivalent quality certification