Global Material and Environmental Compliance Manager, Ultrasound Division
- United States
Responsible for the implementation of Siemens Healthineers Product Related Environmental Protection program (PREP) at Healthineers, Ultrasound Division, which includes compliance to environmental legislations, management of substances of concern, circular economy, energy efficiency and transparency towards customers.
Manages indirect global cross functional resources (multiple sites) to ensure materials used in Ultrasound products are compliant to global material compliance regulations. These include but are not limited to:
- RoHS EU Directive 2011/65/EU as amended by 2015/863/EU
- China RoHS (Administrative Measure on the Control of Pollution Caused by Electronic Information Products, UAE RoHS)
- REACH: EU Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (as amended)
- WEEE: Directive 2012/19/EU (Waste Electrical and Electronic Equipment)
- EU MDR: Section 10.4 of the REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
- Ensure BA US products (including Transducers and Catheters) are using Biocompatible materials as required by ISO10993
- Having proper knowledge for assessing Biological Evaluation of BA US products (including Transducers and Catheters)
- Participates in Healthineers level PREP working groups providing input into corporate level directive and requirements and supporting the development of shared tools and processes.
- Ensures the Ultrasound division complies with Healthineers corporate PREP directives & requirements.
- Owns and manages Ultrasound-specific PREP policies and procedures.
- Manages division level activities and timelines related to Healthineers corporate PREP projects.
- Provides timely internal PREP related reporting for the Ultrasound Division and Healthineers.
- Responsible for timely reporting of any material compliance issues to Healthineers corporate material compliance experts. Determines proper containment and disposition activities as required based on the compliance risk.
- Provides requested PREP information to support sales quotations.
- Responds to customer questions regarding product substances and other PREP information.
- Manages processes to document material compliance for product declaration of conformities.
- Ensures processes are maintained for assuring PREP requirements are reviewed and verified throughout the product lifecycle process.
- BA/BS engineering or material science degree with a minimum of 5 years of experience being actively engaged in implementing regulatory compliance regulation.
- Program & Project Management experience is need for successful outcomes.
- Medical Device experience will be highly weighted.
- Lean Six Sigma experience will be highly weighted.
- SAP experience for navigation to product specifications, ECOs, data field inputs, etc. and/or experience with material compliance software such as BomCheck; Silicon Graphics or similar software is a plus.
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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