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Manufacturing Engineer for CAPA remediation

Northridge, California
  • Bachelor's degree preferably in an engineering or scientific discipline from a four-year college or university
  • 5+ years related experience and/or training; or equivalent combination of education and experience
  • Medical Device experience preferred, will consider experience from other regulated industries such as pharmaceutical
  • A working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, ISO10993,ISO 11135, and the EU Medical Device Directive is a plus
  • Advance knowledge and understanding of Quality Systems and applicable GMP regulations and standards
  • Extensive experience with the CAPA programs, NCMR resolution and TMV

Scope of Services

Manufacturing Support
  • Calibration support, including validating the existing evidence, coordinating with the cross-functional team, writing rationale and execution as needed
  • Identify the severity of CAPA (Major/Minor) in the below mentioned workstreams.
    • Risk management and Design Control
    • Labelling & Packaging 
    • Production control and process validation
    • Other Minor observations in above 3 workstreams 
  • Support in CAPA Assessment, Root cause analysis, Corrective Action
  • Support in CAPA Implementation plan and Effectiveness verification
  • Support Effectiveness Phase closure in TrackWise per the effectiveness plan.

NCMR Activity
  • Supporting to Identify, segregate, evaluate and disposition of Non-Conformance materials/ product.
  • Supporting to prepare trend for the non-conforming product/ material
  • Collaborating with Northridge R&D, Quality, and Process Development to close NCRs

TMV Remediation Activity
  • Complete in-process, final and receiving inspection mapping for several product lines currently manufactured at Northridge site.
  • Perform test method validation for variable and attribute inspections identified in the inspection mapping.
  • Draft protocols to document the strategy for executing a test method validation.
  • Draft reports to document the evidences of TMV completion.
  • Brainstorm possible causes in an event of TMV failure. Initiate and document PFR based on the outcome of TMVs.
  • Route changes to the manufacturing procedures, inspection documents based on the outcome of TMVs.

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