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Site Quality Leader

Company: Disability Solutions
Location: Woburn
Posted on: September 19, 2023

Job Description:

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation. I Am Abiomed - I Am Heart Recovery - Patients First! The Site Quality Leader is responsible for regulatory compliance of production within our Woburn facility. They ensure that all operational quality systems are in compliance with Abiomed internal policies and international medical regulations and quality data is available. They are responsible for supporting the manufacturing and supply chain. Principle Duties and Responsibilities:

  • Lead Manufacturing and Supplier Quality initiatives and support quality metrics, reporting, and help resolve quality issues
  • Lead and support MRB activities ensuring appropriate resourcing to minimize value of MRB material and limit part shortages
  • Conduct external audits of suppliers, execute on CAPA action and effectiveness activities, and support resolution of field complaints
  • Lead/manage and assign tasks for quality goals and initiatives both long and short term with Woburn site team
  • Develop, improve, and maintain existing company quality objectives, and track trend performance.
  • Develop and improve existing quality data systems and provide regular quality data on a global basis
  • Ensure the company has risk based quality processes in place in all areas
  • Support all obsolescence programs with respect to suppliers
  • Ensure quality relevant communication (Global, local, inside and outside the department)

Keywords: Disability Solutions, Boston , Site Quality Leader, Other , Woburn, Massachusetts

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