About this role
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