Overview In this role, you will maintain and improve the Quality Management System to ensure regulatory compliance in a regulated manufacturing setting. You will collaborate with cross-functional teams to uphold product quality and drive continuous improvement. Expect to lead audits, support CAPA and change control, and contribute to risk management and validation activities. This is a chance to shape quality processes in medical devices/pharma environments and support NPI and design transfer.
Responsibilities- Maintain and improve the QMS in line with regulatory standards
- Support compliance with FDA, ISO 13485, ISO 9001, 21 CFR Part 820/QMSR, GMP
- Develop and update SOPs, work instructions, and quality docs
- Manage CAPA, NCRs, deviations, and change control
- Participate in audits and support audit readiness
- Conduct root cause analysis using 5 Whys, Fishbone, and FMEA
- Analyze quality metrics and drive process improvements
- Support supplier quality activities and performance monitoring
- Collaborate with Manufacturing, Engineering, R&D, Regulatory Affairs, Operations, and Supply Chain
- Assist with ISO 14971 risk management
- Support IQ/OQ/PQ validation, document control in eQMS
- Prepare quality reports and management reviews
- Support NPI and design transfer
- Train employees on quality systems and regulatory requirements
Key requirements- Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or related technical discipline
- 2-5+ years in Quality Systems/Quality Engineering/QA in a regulated industry
- Knowledge of QMS and 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 in audits (internal or external)
- Strong analytical, problem-solving, and documentation skills
- Excellent communication and cross-functional collaboration abilities
- Proficiency with Microsoft Office applications
- cross-functional collaboration
- strong communication
- analytical thinking
- CAPA
- Change Control
- Deviations
