Responsibility Responsibility: • Lead, manage and develop quality teams (QC QE, Product release, Complaint investigation, QMS) • Site Management Review and KPI reporting • Establish local process owner for quality sub systems • Drive local quality subsystems • Contribute to global QMS harmonization • Liaise with other departments to ensure quality standards are being met • Develop corrective and preventive actions where necessary • Monitor and review product quality Accountability (result focused)  Quality Management Representative  Ensuring compliance of QM processes and local quality tasks  Improve customer satisfaction  Overseeing the operations and facility  Ensure that products meet the quality requirements Requirements • Minimum Bachelor's Degree in a relevant life-science or engineering field • Proven experience in QM function (10+ years) • In-depth knowledge of FDA and international quality standards (ISO and cGMP) • Proven experience in international medical device industry • Understanding of state-of-the-art QM processes and tools • Managerial and leadership capability • Ability to take initiative and work without close supervision • Experience with in-vitro diagnostic medical devices of great advantage • Excellent computer skills • Excellent analytical and problem-solving skills • Fluent in English Physical Requirements: • 10% of Travel Required • Must be able to sit, stand, walk for long periods of time Our Offer