Overview:
We are seeking a highly skilled and experienced Vice President of Quality Assurance specializing in In Vitro Diagnostics (IVD) consultancy services. This role will lead our quality assurance efforts for IVD products and provide strategic guidance to our clients in the IVD industry.
Responsibilities:
Provide strategic leadership in quality assurance for IVD products, overseeing consultancy projects and ensuring compliance with regulatory standards (FDA, ISO, etc.).
Lead the development and implementation of robust quality management systems (QMS) tailored to various IVD products and client needs.
Offer expert guidance and advisory services to clients on quality-related matters, including regulatory compliance, quality system setup, and improvement strategies.
Collaborate with cross-functional teams to develop comprehensive quality assurance strategies for clients, spanning from product development to market release.
Conduct audits, assessments, and risk analyses for clients to identify areas for enhancement and ensure adherence to IVD device quality standards and regulations.
Stay updated with industry trends, emerging regulations, and technological advancements in IVD quality assurance methodologies to provide cutting-edge consultancy services.
Requirements:
Advanced degree in Engineering, Life Sciences, or a related field.
8+ years of extensive leadership experience in quality assurance within the IVD medical device industry, preferably in consultancy roles.
Proven success in developing and implementing tailored QMS solutions for IVD products and guiding clients through regulatory compliance.
Exceptional leadership skills with the ability to provide strategic direction and mentorship to teams and clients.
Strong problem-solving, analytical, and decision-making abilities.
Excellent communication and client-facing skills, capable of articulating complex concepts to diverse stakeholders.
Benefits:
Competitive compensation package with executive-level benefits.
Opportunities for professional growth and career advancement in the consultancy field.
Collaborative and dynamic work environment focused on delivering high-quality consultancy services in the IVD sector.
Health and wellness programs.