Director of Quality - Kelly Services : Job Details

#x 9; Oversee the development, implementation, and continuous improvement of the Quality Management System (QMS) from development to operations, ensuring compliance with industry regulations and standards. qualifications. Ensure ongoing compliance with FDA, ISO 13485, ISO 9001, and other applicable regulations and standards. Lead internal and external audits, including but not limited to ISO audits, FDA inspections, and supplier audits Serve as the quality representative in design and process validations, risk assessments, and regulatory submissions. Mentor and lead QA/ QC team, ensuring continued development and compliance Direct the CAPA process, including root cause analysis and effectiveness verification. Oversee document control, training programs, complaints, cleanroom certification, calibrations, and change control. Establish and monitor quality metrics, KPIs, SOPs, and management review activities. Collaborate cross-functionally to support product development and commercializa...Director, Quality Assurance, Product Development, Technology, Staffing, Quality