Director of Quality Management
About The Position
The Director of Quality Management leads and develops quality teams covering quality control, quality engineering, product release, complaint investigation, and the quality management system. The role oversees site management reviews and KPI reporting, establishes local process owners for quality subsystems, drives local quality subsystems, and contributes to global QMS harmonization. The director works with other departments to ensure quality standards are met, develops corrective and preventive actions where necessary, and monitors and reviews product quality. Accountability includes serving as the Quality Management Representative, ensuring compliance of quality management processes and local quality tasks, improving customer satisfaction, overseeing operations and the facility, and ensuring products meet quality requirements. The role requires 10% travel and the ability to sit, stand, and walk for long periods.
Requirements
- Bachelor’s degree in a relevant life-science or engineering field.
- 10+ years of proven experience in a quality management function.
- In-depth knowledge of FDA and international quality standards, including ISO and cGMP.
- Proven experience in the international medical device industry.
- Understanding of state-of-the-art quality management processes and tools.
- Managerial and leadership capability.
- Ability to take initiative and work without close supervision.
- Excellent computer skills.
- Excellent analytical and problem-solving skills.
- Fluent in English.
- Able to sit, stand, and walk for long periods.
- Able to travel 10%.
Nice To Haves
- Experience with in-vitro diagnostic medical devices is a great advantage.
Responsibilities
- Lead, manage, and develop quality teams covering QC, QE, product release, complaint investigation, and QMS.
- Conduct site management reviews and KPI reporting.
- Establish local process owners for quality subsystems.
- Drive local quality subsystems and contribute to global QMS harmonization.
- Liaise with other departments to ensure quality standards are met.
- Develop corrective and preventive actions where necessary.
- Monitor and review product quality.
- Serve as the Quality Management Representative.
- Ensure compliance of QM processes and local quality tasks.
- Improve customer satisfaction.
- Oversee operations and the facility.
- Ensure products meet quality requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Director
