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.

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