- You will be directing a worldwide organization in alignment with FDA, EU MDR and other applicable regulations and standards for Post-Market Surveillance and Risk.
- You will be responsible for leading a team of experts as they manage the product portfolio’s post-market data, adverse event reporting, trending metrics and recalls.
- You will provide guidance and governance for a team of experts as they execute a product Risk Management program.
- You will participate in influencing the Organization to achieve higher quality standards and practices into design and development processes
- You will identify opportunities for efficiency and lean processes
- You have 7+ years of quality experience in medical device and are innately familiar with ISO 13485, ISO 14971, FDA 21 CFR 803, 21 CFR 806 and EU MDR.
- You have design and development experience to offer interpretation of applicable Standards & Regulations to those not familiar with the objectives.
- You have moderate to expert knowledge of diagnostic ultrasound and its clinical utility
- You manage others well and have strong influential skills for those employees you don’t manage
- Willingness to travel and schedule flexibility to accommodate global locations
- You have very good presentation skills when communicating with senior management
- Bachelor’s degree or equivalent experience required. Related engineering, science, or medical/clinical disciplines preferred.
- Minimum of 5 years in medical device quality experience.
- Willing to travel up to 10%
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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