What are the responsibilities and job description for the Quality Engineer position at Katalyst CRO?
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.