Director of Quality Management
Greiner Bio-One Americas · Monroe, NC · 1 wk ago
On-siteQuality AssuranceFull-time
Responsibilities
- 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
Accountabilities
- 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