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Senior Manufacturing Quality Engineer
Не указаноПолная занятостьManufacturing Quality ManagementMedical Devices
Six-month contract role supporting quality and regulatory compliance across Class III medical device manufacturing. Work with Manufacturing, Operations, R&D, and Supply Chain to improve quality systems and production processes.
Обязанности
- Maintain and improve the Quality Management System in line with ISO 13485, EU MDR, and FDA QSR requirements
- Support manufacturing operations, validation, and material review board activities
- Oversee CAPA, nonconformances, deviations, complaints, risk management, change controls, document control, and training
- Prepare for, support, and follow up on internal and regulatory audits
- Partner with R&D, Regulatory Affairs, Operations, and Supply Quality teams
- Review and approve quality documentation, work instructions, and SOPs; support training and risk assessments
- Lead investigations into nonconformances, deviations, and CAPAs, including root cause analysis and corrective and preventive actions
Требования
- Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or a related field
- At least 7 years of quality assurance production experience in the medical device industry
- In-depth knowledge of FDA 21 CFR Part 820, ISO 13485/14971, and EU MDR
- Hands-on experience with engineering change orders, nonconformance management, CAPA, and root cause analysis tools
- Strong written and verbal English communication skills
Будет плюсом
- Knowledge of Lean, Six Sigma, or continuous improvement methods
- Ability to work effectively in a fast-paced, cross-functional manufacturing environment
Условия и преимущества
- Competitive compensation and flexible benefits package
- Eligible for the Medtronic Incentive Plan short-term incentive