Staff Quality Engineer
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
Requirements
- Education: bachelor’s degree in biology, chemistry, biotechnology or similar
- Must have hands on lab experience
- Must have process validation experience
- 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.