Quality System engineer

Roles & Responsibilities

• Maintain and improve the Quality Management System (QMS) in compliance with applicable regulatory and quality standards.
• Support compliance with FDA regulations, ISO 13485, ISO 9001, 21 CFR Part 820/QMSR, GMP, and other applicable standards.
• Develop, review, and update Standard Operating Procedures (SOPs), work instructions, and quality documentation.
• Manage and support Corrective and Preventive Actions (CAPA), Nonconformance Reports (NCRs), deviations, and change control activities.
• Participate in internal, supplier, customer, and regulatory audits and support audit readiness.
• Perform root cause investigations using quality tools such as 5 Whys, Fishbone Diagram, and Failure Mode and Effects Analysis (FMEA).
• Analyze quality metrics and identify opportunities for continuous process improvement.
• Support supplier quality activities, including supplier qualification, audits, and performance monitoring.
• Collaborate with Manufacturing, Engineering, R&D, Regulatory Affairs, Operations, and Supply Chain to resolve quality issues.
• Absorb and support risk management activities in accordance with ISO 14971 (for medical device environments).
• Support equipment, process, software, and product validation activities (IQ/OQ/PQ) as required.
• Ensure document control processes are followed within the electronic Quality Management System (eQMS).
• Prepare quality reports, trending analyses, and management review presentations.
• Support new product introduction (NPI) and design transfer activities.
• Train employees on quality system procedures and regulatory requirements.

Requirements

• Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or a related technical discipline.
• 25+ years of experience in Quality Systems, Quality Engineering, or Quality Assurance within a regulated industry.
• Knowledge of Quality Management Systems (QMS) and applicable regulatory requirements.
• Experience with CAPA, Change Control, Deviations, NCRs, and Document Control.
• Familiarity with FDA regulations, ISO 13485, ISO 9001, GMP, and 21 CFR Part 820/QMSR.
• Experience participating in internal or external audits.
• Strong analytical, problem-solving, and documentation skills.
• Excellent communication and cross-functional collaboration abilities.
• Proficiency with Microsoft Office applications.