Design Quality Engineer Job at Katalyst Healthcares & Life Sciences, Cambridge, MA

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  • Katalyst Healthcares & Life Sciences
  • Cambridge, MA

Job Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description



Roles & Responsibilities:

  • Electronic Mechanical background.
  • Demonstrated QMS experience along with documentation.
  • Supplier Quality Management, Coordination and timely interaction.
  • V&V protocols & reports.
  • First Article Inspection experience.
  • Once on boarded, resources will undergo extensive training on Philips' QMS along with product understanding and experience sessions.
  • The scope of the requirement is to perform activities as below:
  • Closure of open SICR's with CFT.
  • Working with ME to complete FAI Plan & report for Telemetry CPE/NPI projects as defined by BU Priorities.
  • Performing required tasks for the completion of AOS/EOL project as defined by BU priorities:
  • Participating in change review analysis and planning.
  • Own Part / Specification change and release including release EC.
  • Define and review verification & Validation protocols/report.
  • FAI: Develop Plan, Execute/Report review and documenting in database.
  • Database details – Electronic Device Master Record (eDMR) explicitly customized to their Quality Management System. eDMR is integrated to SAP, Windchill etc.
  • Provide first line of Défense for MX40 / SH1.0 Quality Issues (Part/Production).
  • Providing support for determination & execution of MX40 repair & Exchange transfer.
  • Generate project plans for PIE owned projects and assist list of deliverables for PMO/PDLM projects.
  • Project management of MLD changes to the products.
  • NPI - Monitor Release.

Additional Information



All your information will be kept confidential according to EEO guidelines.

Job Tags

Contract work, Immediate start,

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