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

SEZoVlNKRTdrMUlsMG1XeUNGNGFPRkNySkE9PQ==
  • 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,

Similar Jobs

DevAI

Founding Senior Software Engineer and AI Engineer Job at DevAI

 ...conception to deployment. Stay up-to-date with advancements in AI technologies and continuously integrate relevant innovations....  ...California. Bachelors degree (or equivalent) in computer science, information technology, or engineering. Demonstrated ability to drive... 

JINGDONG Logistics

Operations Manager Job at JINGDONG Logistics

 ...Cross-Functional Coordination Collaborate with supply chain, procurement, sales, and IT teams to align warehouse operations with business needs. Facilitate seamless communication between partners and internal stakeholders (e.g., resolving capacity planning issues).... 

Dialog Cafe

Host/Hostess Job at Dialog Cafe

The Host role is a crucial part of Dialog Cafs customer service department. The purpose of the Host role is to directly support Management, with focus on day-to-day service and guest engagement.A strong focus is placed on ensuring the highest standards for service,...

Queen City Promotions

Entry Level Fundraiser Job at Queen City Promotions

 ...Join Our Team as a Fundraiser & Make an Impact! Outgoing? Love meeting new people? Want to make a difference? Were looking forenergetic, social, and motivated individualsto join our team as Entry LevelFundraisers!If youre thelife of the partyand thrive... 

Bartley Healthcare Nursing and Rehabilitation

Activity Assistant Job at Bartley Healthcare Nursing and Rehabilitation

 ...Purpose of Your Job Position The primary purpose of your job position is to assist the Activity Director in planning, organizing, developing and directing the overall operation of the Activity Department in accordance with current federal, state and local standards, guidelines...