- You will work with cross-functional leadership to develop and manage an Ultrasound Quality Management System that drives global regulatory compliance, product quality, and business breakthrough targets.
- You will drive CAPA and Internal Audit programs for the identification and remediation of deficiencies that hinder development of best-in-class Ultrasound products.
- You will refine and manage a global KPI system and associated quality operations and management reviews.
- You will drive the identification and execution of training strategies that elevate the combined expertise of our Ultrasound business.
- Your people management skills will unlock your team’s leadership capabilities and mentor their continued career growth.
- Your global mindset will be leveraged in a global design and manufacturing environment.
- Your project/change management skills (e.g. Lean, 6-Sigma, HPS) expertise will ensure the success of multiple process and IT system rollouts.
- Your creativity and excellence in execution will ensure the success of the multiple business changes you will be driving.
- Your deep understanding of regulatory intent will enable your development of a value-add QMS that operates beyond baseline compliance
- Minimum of 5-8 years’ experience with internationally distributed regulated medical devices (e.g. 21 CFR 820, ISO 13485)
- Experience with external regulatory authority and notified body audits (e.g. FDA, MHLW, ANVIS)
- Willing to travel internationally up to 20%
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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