In-depth understanding of regulatory requirements for medical devices and quality systems (FDA, MDR, ISO13485, etc.), coupled with familiarity in medical device design, manufacturing, and testing.
Meticulous attention to detail, demonstrating precision and thoroughness in quality-related processes and documentation.
Exceptional communication skills, with the ability to lead and inspire individuals across all levels.
Robust analytical and problem-solving skills, essential for addressing quality issues and navigating compliance challenges.
Advocates for a risk-based approach, maintaining strict standards where necessary while being mindful of resource constraints.
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