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Tier-1 brand attracts applicants but specialized medical-device quality/regulatory skills narrow the pool.
Medical-device quality and regulatory requirements significantly limit cross-industry transferability.
Mandatory medical-device regulatory experience and ISO/FDA expertise make screening stringent.
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Drive compliance activities and oversee the total quality management system for a specific product, site, or region in healthcare quality.
Ensure quality and regulatory compliance, manage quality metrics, and represent the company to external agencies.
Utilize analytical thinking and technical expertise to propose solutions and prioritize data analysis to maintain and improve quality standards.
Experience Required: Advanced experience in Quality & Healthcare Quality, with equivalent academic credentials of at least a Bachelor's degree or high school diploma plus relevant experience.
Mandatory domain experience in medical device industry quality processes.
Knowledge and working experience with ISO 13485, FDA CFR 820, EU MDR, and country specific regulations.
Relocation assistance: Not provided.
Experienced in managing quality compliance within healthcare or medical devices involving regulatory standards.
Able to operate with autonomy within defined policies, capable of leading small projects and resolving day-to-day issues with technical judgment.
Skilled in cross-functional collaboration and able to influence quality culture through metrics, reporting, and process improvements.