Quality Engineer Focusing Medical Device Compliance Strategies

Position: Dynamic Quality Engineer Focusing on Medical Device Compliance Strategies
Be a key player in quality assurance for medical devices as a proactive Quality Engineer. Utilize your solid foundation in FDA regulations and validation processes to foster compliance and continuous improvement.

This role requires a commitment to quality within a regulated environment, supporting quality systems and leading CAPA initiatives. Engage in cross-functional collaborations to implement process improvements while ensuring adherence to regulatory standards during audits and documentation review.

Key Responsibilities:

• Support quality systems for regulatory compliance

• Lead CAPA investigations and conduct root cause analysis

• Maintain, review, and update quality documentation

• Collaborate with teams for effective process improvements

• Assist in managing audits and resolving findings promptly

Requirements:

• 3+ years of experience in Quality Engineering for medical devices

• Strong knowledge in FDA regulatory frameworks and ISO 13485

• Experience with CAPA, NCR, and Root Cause Analysis methodologies

• Hands-on validation experience, including IQ/OQ/PQ

• Understanding of risk management and documentation procedures

Enhance your career by ensuring compliance and driving quality in medical devices, contributing directly to patient safety and satisfaction.
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