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 ISO9001. IATF16949, ISO13485, 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.