Quality Engineer

Quality Engineer

We are seeking a highly skilled and detail-oriented Quality Engineer to join our dynamic team. The successful candidate will play a crucial role in ensuring the quality and reliability of our products through the implementation of effective quality control processes and procedures. As a Quality Engineer, you will collaborate with cross-functional teams to identify areas for improvement, develop testing strategies, and drive continuous process enhancements to meet or exceed customer expectations.

Job Duties

• Develop and implement quality control procedures and processes to ensure compliance with FDA regulations and industry standards.
• Conduct quality audits to identify areas for improvement and implement corrective actions.
• Collaborate with cross-functional teams to establish and maintain quality assurance and quality control (QA/QC) programs.
• Monitor and evaluate product quality throughout the manufacturing process, from raw materials to finished goods.
• Perform quality inspections and tests to identify defects or deviations from specifications.
• Analyze data and trends to identify root causes of quality issues and develop solutions for process improvement.
• Provide guidance and support to production teams to ensure adherence to quality standards.
• Participate in project management activities, including the development of project plans, timelines, and deliverables.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements.

Qualifications

• Bachelor's degree in Engineering, Metallurgical, Chemistry or technical discipline.
• Proven experience in quality engineering or a related role.
• Strong knowledge of FDA regulations, cGMP, and HACCP principles.
• Certification as a Quality Engineer preferred.
• Advanced Knowledge of ISO
  9001. IATF
  16949, ISO
  13485, AS9100 and/or Nadcap standard.
• Experience with quality management systems and tools.
• Proficient in analyzing data and using statistical methods for quality control purposes.
• Excellent project management skills, with the ability to prioritize tasks and meet deadlines.
• Strong attention to detail and problem-solving abilities.
• Excellent communication skills, both verbal and written.

Note:

This job description is intended to provide a general overview of the position. Duties, responsibilities, and qualifications may be adjusted based on the needs of the company.