Quality Engineer

Responsibilities

• Develop, implement, and maintain robust quality management systems aligned with industry standards such as ISO 13485, ISO 9001, and regulatory requirements including FDA regulations.
• Conduct regular quality audits across manufacturing processes to identify areas for improvement and ensure compliance with internal policies and external standards.
• Perform detailed quality inspections and control checks at various stages of production to verify product specifications and detect deviations.
• Collaborate with cross-functional teams to establish quality assurance protocols that support manufacturing efficiency while maintaining product integrity.
• Lead root cause analysis investigations for non-conformances or product defects; develop corrective and preventive actions (CAPA) to address issues effectively.
• Support validation activities for manufacturing equipment and processes in accordance with CGMP guidelines.
• Monitor key performance indicators related to quality metrics; prepare reports for management review.
• Facilitate training sessions on quality systems, regulatory compliance, and best practices for staff involved in production and quality assurance.
• Coordinate with suppliers and vendors during supplier qualification audits to ensure raw materials meet required standards.
• Participate in project management activities related to new product development or process improvements aimed at enhancing product quality.
• Maintain comprehensive documentation of quality procedures, audit findings, inspection reports, and corrective actions.

• Bachelor's degree in Engineering, Quality Management, or a related field; advanced certifications such as CQE (Certified Quality Engineer) are preferred.
• Proven experience in a Quality Engineer role within manufacturing environments, especially regulated industries such as medical devices or pharmaceuticals.
• Extensive knowledge of ISO 13485 standards for medical devices, FDA regulations (21 CFR Part 820), HACCP principles, CGMP practices, and ISO 9001 quality management systems.
• Strong background in conducting quality audits, inspections, and implementing QA/QC procedures.
• Familiarity with manufacturing processes including process validation and equipment qualification.
• Excellent analysis skills with the ability to identify root causes of issues quickly and develop effective solutions.
• Proficiency in using quality management software and data analysis tools.
• Effective project management skills with the ability to prioritize tasks efficiently.
• Strong communication skills to collaborate effectively across departments and with external partners.