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)
ï‚§ Â Â Quality Management Representative
ï‚§ Â Â Ensuring compliance of QM processes and local quality tasks
ï‚§ Â Â Improve customer satisfaction
ï‚§ Â Â Overseeing the operations and facility
ï‚§ Â Â Ensure that products meet the quality requirements
Requirements
•   Minimum Bachelor's Degree in a relevant life-science or engineering fieldÂ
•   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 toolsÂ
•   Managerial and leadership capability
•   Ability to take initiative and work without close supervision
•   Experience with in-vitro diagnostic medical devices of great advantageÂ
•   Excellent computer skillsÂ
•   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
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