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Manufacturing Quality Engineer

San Diego, CA, US • Posted 10 hours ago • Updated 10 hours ago

Contract W2

Contract Corp To Corp

No Travel Required

Able to Sponsor

On-site

$38 - $40/hr

Fitment

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Job Details

Skills

Manufacturing Engineer
Manufacturing
Root Cause Analysis
Regulatory Compliance
ISO 13485
OQ
IQ
PQ
Agile
Change Control
Medical Devices

Summary

5 to 6 years of medical devices or diagnostic equipment manufacturing experience
Manage the end-to-end validation documentation lifecycle including authoring, reviewing and approving protocols (URS, IQ, OQ, PQ, PV, TMV, RTM, VSR) Change Controls and Periodic Reviews, ensuring alignment with site VMP and ISO 13485.
Lead cross-functional validation initiatives for lab equipment, facilities, and non-product software supporting diagnostics platforms
Qualify GXP equipment in compliance with FDA 21 CFR Part 11, 211. Support entire equipment lifecycle from qualification till decommissioning.
Collaborated with QA and manufacturing teams to conduct deviation management and QI/ CAPA investigations, executing root cause analysis (5 Whys Fishbone).
Applied statistical tools (ANSI/ASQ Z1.4 sampling plan) and tools such as Normality test, Distribution analysis, control charts and to support method validation, trending and ensure process robustness.
Apply GAMP5 risk-based validation framework for assessing and validating non product software systems used in quality and manufacturing environments and authoring NPSW documentations.
Driving agile change control process for release of agile production documents.
Conduct gap analyses on method validation processes, environmental monitoring, and equipment qualification, aligning them with industry and regulatory standards.
Supporting VRB meetings, documenting validation metrics, tracking goals and addressing escalation for resolution and approval.
Support external and internal audit responses by preparing validation documentation and aligning with GxP compliance and audit readiness goals.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10426508
Position Id: 8938229
Posted 10 hours ago

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