Quality Engineer

Job Responsibilities:

• Conduct inspections and testing of products, materials, and equipment to ensure they meet quality standards and specifications.
• Identify areas for quality improvements within production processes, and develop corrective actions to address defects or deviations.
• Ensure all products and processes comply with company, customer, and regulatory standards (ISO, FDA, etc.).
• Create and maintain detailed records of test results, inspection reports, and corrective actions taken.
• Investigate product defects, analyze root causes, and implement corrective and preventive measures.
• Work closely with cross-functional teams, including production, engineering, and suppliers, to ensure quality throughout the production lifecycle.
• Assist in internal and external quality audits, and provide necessary documentation for regulatory reviews.
• Educate and train production staff on quality standards, testing procedures, and regulatory requirements.
• Evaluate and qualify suppliers to ensure that incoming materials meet quality specifications.

Qualifications:

• Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or related field) or equivalent.
• Minimum of 3-5 years of experience in a quality control or quality assurance role, preferably in pharmaceutical manufacturing.
• Strong understanding of quality standards like ISO 9001, Six Sigma, and regulatory requirements.
• Familiarity with statistical process control (SPC) and quality management systems (QMS).
• Experience with testing equipment and tools (e.g., CMM, calipers, micrometers).
• Excellent analytical and problem-solving skills.
• Strong attention to detail and accuracy.
• Ability to communicate effectively with cross-functional teams.
• Proficiency in Microsoft Office, ERP systems, and quality management software.
• Certification in quality control, such as Six Sigma Green Belt, ASQ Certified Quality Engineer (CQE), or similar.