Quality Systems Engineer
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.