Job-ID32574827Reference26-01226 Remote 50% Remote Job Description: We are seeking a Quality Systems Engineer to support and maintain the Quality Management System (QMS) in a regulated manufacturing environment. The ideal candidate will ensure compliance with applicable regulatory requirements, support quality system processes, lead continuous improvement initiatives, and collaborate with cross-functional teams to maintain product quality and regulatory compliance. Experience in medical devices, pharmaceuticals, biotechnology, or other regulated industries is highly preferred.
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 (Client), 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. Assist with 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. 2–5+ 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.
