EDWARDS LIFESCIENCES LLC – $129,854.00/Year

Contd from H.8 In lieu of a Masters degree and 8 years of experience, employer will accept a Bachelors degree or equivalent in any Engineering, Manufacturing or Sciences field and 10 years of progressive experience deploying global supply chain and quality transformational programs to include any relevant job titles within this occupation in the medical device industry.br br Contd from H.10B and quality transformational programs to include any relevant job titles within this occupation in the medical device industry.br br Contd from H.12 Job requirements are normal for the employer due to the complexity of job duties associated with this position. Employer answered no to Question H.12 based on SVP analysis only.br br Work experience to include 1. Manufacturing engineering in the medical device industry. 2. Utilizing Microsoft Office Suite to manage deliverables and using the following tools and systems JDE, Concur, SharePoint, LeanKit, and ePAC. 3. Preparing written reports and presentations on systems status and health for management and internal customers or stakeholders. 4. Working with crossfunctional teams including GSC, Manufacturing, Quality, and Regulatory to ensure compliance with internal and external policies and procedures, FDA regulations and at least 2 other regulatory bodies. 5. Building external and internal relationships with functional heads, process owners, and stakeholders. 6. Managing a team and providing coaching and feedback, including responsibility for all employee actions including hiring and firing authority and partnering with HR on all aspects of employee relations while managing crossfunctional stakeholders. 7. Building strategic approaches for regulatory and quality functions; this should include program management and program governance for digital roadmap and systems for global supply chain. 8. Quality assurance experience including management of CAPAs, receiving inspection, inprocess inspection and DHR related activities. 9. Conducting failure mode effect analysis FMEA for medical devices manufacturing. 10. Working with crossfunctional teams and third parties to drive improvements in regulatory processes through application of lean principles, six sigma tools, value stream mapping VSM, and technologies. 11. Managing enterprise processes and business systems. 12. Experience in platform ecosystem and integration points within core manufacturing systems. Position requires 10 domestic and 10 international travel; expenses paid by employer.br Hiring Requirements Drug TestingScreening, Background Checks.