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Description:

Responsible for performing process, equipment, and software validation activities including, but not limited to, gathering historical data for product manufacture, analyzing data using statistical principles, writing validation protocols and reports, GDP review of data and reports, and final approval of 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. May be responsible for leading teams to perform validation activities or perform as a member of the team. 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)
Acts as Quality Assurance reviewer/approver or author for validation protocols, reports, and deviations.
Provides and applies quality engineering direction to projects using quality engineering and statistical principles
Root Cause Analysis
FMEA
Risk Management and Mitigation
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
Demonstrates working knowledge and application of applicable regulatory requirements
Other duties as assigned.

Requirements:
Education: bachelor's degree

Experience (preferred):
Experience in a quality related 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
Certified Quality Engineer
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