Jobs at Onward Technologies Inc
View all jobs
Manufacturing Engineer for CAPA remediation
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
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.
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.
Share This Job