Key Responsibilities:
Quality Assurance & Control
- Develop, implement, and maintain QA procedures and standards.
- Conduct inspections, audits, and testing of raw materials, in-process items, and finished products.
- Identify defects, non-conformities, and process deviations and recommend corrective actions.
Documentation & Reporting
- Maintain accurate QA documentation, test reports, and compliance records.
- Prepare reports on quality metrics, trends, and improvement initiatives for management.
- Ensure compliance with ISO standards, GMP, and other regulatory requirements.
Process Improvement
- Analyze production processes to identify areas for quality improvement.
- Collaborate with engineering and production teams to implement corrective and preventive actions (CAPA).
- Support continuous improvement initiatives and lean quality practices.
Testing & Validation
- Conduct product testing, validation, and verification in accordance with specifications.
- Review design and production changes to ensure adherence to quality standards.
- Assist in equipment calibration and maintenance for accurate quality assessment.
Collaboration & Training
- Work closely with cross-functional teams to resolve quality issues and enhance processes.
- Train production staff on quality standards, procedures, and best practices.
- Participate in audits, inspections, and certification processes.
Required Qualifications:
- Bachelor's degree in Engineering, Science, or related field.
- 4–8 years of experience in quality assurance or quality control in manufacturing or production.
- Strong knowledge of QA methodologies, ISO standards, GMP, and inspection techniques.
- Proficiency in quality management systems and documentation practices.
- Excellent analytical, problem-solving, and communication skills.