Senior Quality Engineer Overview We are seeking an experienced Senior Quality Engineer to lead digital quality initiatives and support the integration of automated, data-driven processes across manufacturing and quality systems.
This role will ensure regulatory compliance (FDA, EU MDR, ISO *****) and drive continuous improvement of digital workflows, MES, ERP, and eLHR systems.
Key Responsibilities Maintain and improve the Quality Management System (QMS) in line with ISO ***** and FDA standards.
Lead and mentor a small team while supporting digital transformation of quality processes.
Ensure compliance with regulatory requirements and data integrity across digital platforms.
Collaborate with cross-functional teams to embed quality assurance into MES, ERP, and other systems.
Conduct and support IQ/OQ/PQ validation for digital equipment and software.
Manage CAPAs, SCARs, and non-conformance documentation; support internal and external audits.
Implement and monitor predictive analytics and AI tools for quality improvement.
Provide guidance on data governance, cybersecurity, and traceability.
Ensure compliance with 21 CFR Part 11 and electronic records validation.
Qualifications Bachelors degree in Engineering, Quality, or a related field.
5+ years of experience in quality engineering within a regulated manufacturing environment.
Strong understanding of FDA, ISO *****, and EU MDR standards.
Experience with digital quality systems, MES, ERP, and eLHR.
Excellent communication skills across technical and non-technical teams.
Knowledge of DHR/DMR processes and digital documentation systems preferred.