Description

You will lead quality initiatives and ensure compliance with manufacturing standards and regulatory requirements.

Responsibilities

• Lead and maintain the ISO 9001:2015 Quality Management System to ensure compliance and continuous improvement.
• Implement and oversee Statistical Process Control (SPC) across manufacturing operations to monitor product quality.
• Supervise and mentor a team of quality engineers and technicians.
• Manage the Corrective and Preventive Action (CAPA) process, including root cause analysis.
• Conduct Failure Mode and Effects Analysis (FMEA) to mitigate risks in design and process stages.
• Oversee supplier quality management through audits, performance evaluations, and corrective action tracking.
• Perform internal audits to evaluate QMS effectiveness and drive improvements.

Required Skills

• 5+ years of experience in quality engineering, preferably in manufacturing.
• Direct experience with ISO 9001:2015 and regulatory standards.
• Proficiency in SPC, CAPA, and FMEA methodologies.
• Knowledge of quality control plans, inspection criteria, and documentation.
• Experience with Lean and Six Sigma tools and techniques.
• Ability to lead teams and manage cross-functional projects.
• Bachelor's degree in Engineering or a related field.

Preferred Skills

• Advanced degree in Engineering or a related field.
• Certified Quality Engineer (CQE) or similar certification.

Key Skills

Education

Bachelor's degree