Ensure compliance with established standards and regulations within the organization’s quality area.
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Minimum of 5 years of experience in the medical devices industry in QA or RA functions.
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Previous leadership experience.
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Strong knowledge of compliance requirements in the medical device industry, including audits under FDA QSR, ISO 13485, or other similar standards.
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Experience in internal and supplier audits, risk-based approaches, and CAPA.
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Bilingual in English and Spanish (reading, writing, and speaking).
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Strong analytical, problem-solving, and data-driven decision-making skills.
