Product Quality Engineer
: Job Details :

Serve as the Quality Assurance lead on product and analytical method development projects, ensuring alignment with internal QMS and external Quality Technical Agreements (QT - As). Support compliance activities related to change control, risk management, validation, design control, and nonconformance handling. Collaborate with clients and internal teams to define roles and responsibilities, and negotiate and implement QT - As. Participate in audits and regulatory inspections, coordinating response efforts and supporting design assurance as needed. Review and approve quality documentation, including change controls, SOPs, batch records, analytical reports, specifications, nonconformances, and CAPAs. Provide training and consultative support on quality systems and processes to promote a strong quality culture. Drive continuous improvement initiatives within the QMS and contribute to system and procedural enhancements. Respond to customer inquiries and regulatory requests with clarity and...Quality Engineer, Quality Assurance, Engineer, Product, Quality, Technology