Sr. Quality Engineer

Primary Function of Position This role executes and maintains advanced QA systems, leads complex investigations and validations, and provides technical expertise for compliance with internal, regulatory, and industry standards. Essential Job Duties • Manage quality assurance projects, validations, and process audits. • Lead technical investigations and CAPA resolution for critical issues. • Oversee process improvement initiatives for quality systems. • Author, review, and approve QA documentation and protocols. • Support regulatory and customer audit preparations and responses. • Advise cross-functional teams on quality requirements. • Analyze and interpret advanced quality data and KPI trends. • Mentor QA engineers and technicians in technical expertise. • Ensure full adherence to GMP, ISO, FDA, and other standards. • Recommend adoption of new QA tools or software to improve efficiency. Required Experience and Education • Minimum 8 years of experience in quality assurance and bachelor’s degree in a relevant discipline, or equivalent combination of education and experience. English proficiency required Required Knowledge, Skills and Abilities • Expertise in QA systems, validations, and regulatory compliance. • Advanced project management and technical analysis skills. • Leadership in root cause analysis and CAPA methodology. • Outstanding documentation and reporting abilities. • Ability to influence cross-functional process improvements. Physical Requirements • Office production and lab movement. • Occasional travel for audits or projects. • Occasional lifting (