Staff Quality Engineer
Company: millenniumsoft
Location: San Jose
Posted on: April 2, 2026
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Job Description:
Position : Staff Quality Engineer Location : San Jose, CA
Duration : 5 Months contract Total Hours/week : 40.00 1 st Shift
Client: Medical Device Company Level Of Experience: Mid-Level
Employment Type: Contract on W2 (Need US Citizens Or GC Holders
Only) Job Description: Responsible for performing process,
equipment, and software validation activities including, but not
limited to, performing laboratory studies and validations using
laboratory techniques, gathering historical data for product
manufacture, analyzing data using statistical principles, writing
process validation protocols and reports, technical review of data
and reports, and final approval of process validation protocols,
reports, and deviations. May interact in cross-functional teams
including Reagent Manufacturing Engineers and Chemists, Research
and Development, and Quality Assurance Validation Engineers. Will
work within cross-functional teams but may be required to work
independently. Will simultaneously work on multiple projects.
Knowledge of general reagent manufacturing processes, antibody
purification and conjugation, and flow cytometry, is preferred.
Process, Test Method, Equipment, and Software Validations used in
IVD product manufacture (IQ, OQ, PQ) Works in lab performing hands
on studies Review/approve or author for validation protocols,
reports, and deviations. Provides and applies direction to projects
using quality and statistical principles Root Cause Analysis FMEA
DOE Measurement Systems Analysis Sampling and Control Plans Post
Market Surveillance Trend Review Process Capability Provides and
applies scientific technical principles/concepts Follows company
procedures Other duties as assigned. Requirements: Education:
bachelor’s degree in biology, chemistry, biotechnology or similar
Must have hands on lab experience Must have process validation
experience Experience (preferred): Experience in a manufacturing or
R&D function in a medical device or other FDA regulated
environment. Previous work with IVD reagent products under GMP
conditions Process validation (IQ, OQ, PQ) and test method
validation experience Software validation experience Knowledge of
general reagent manufacturing processes, antibody purification and
conjugation, flow cytometry Six Sigma Certification Knowledge of
applicable regulatory requirements including ISO13485, ISO14971,
ISO9001, quality systems regulations (21 CFR: 820) Training in
statistics. Experience with Minitab or other statistical software,
MS Excel, and MS Word required.
Keywords: millenniumsoft, Davis , Staff Quality Engineer, Science, Research & Development , San Jose, California
