DHF Quality Systems Engineer – Medical Devices

ECI is seeking a DHF Engineer to join the Regulatory Compliance Work Stream. You will establish Quality Systems aligned with 21 CFR 820 and ISO 13485, while supporting regulatory compliance across multiple client sites and markets.

You will drive quality improvement initiatives, develop SOPs, and collaborate with stakeholders to resolve complex non-compliant issues. You will also help draft proposals, run audits, and keep abreast of regulatory changes in product registration and post-market

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