Contract Quality Engineer

Job Summary

We are seeking a dedicated and detail-oriented Quality Engineer to join our manufacturing team. In this role, you will oversee the development, implementation, and maintenance of quality systems to ensure products meet rigorous standards and regulatory requirements. The ideal candidate will possess a strong understanding of quality assurance and control processes, including compliance with ISO 13485, FDA regulations, HACCP, CGMP, and ISO 9001 standards. Your expertise will drive continuous improvement initiatives, conduct comprehensive quality audits, and support manufacturing operations to uphold the highest levels of product safety, efficacy, and customer satisfaction.

Duties

• 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.

Qualifications

• 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. If you are committed to ensuring excellence in product quality through rigorous standards and continuous improvement initiatives, we encourage you to apply for this vital role. Join us in advancing our mission of delivering safe, reliable products that meet the highest industry standards.