Sr. Quality Engineer
- Use/application of investigative tools to perform investigations and root cause analysis for manufacturing and R&D projects and quality processes.
- Performing FMEA analysis, RCA, Gauge R&R studies, statistical evaluation, and process control activities to resolve and prevent quality and reliability concerns.
- Monitoring the metrology and calibration activities to ensure quality objectives are being met and that adequate procedures and work instructions are in place.
- Preparing quality/inspection plans, procedures and instructions, and product / raw materials specifications.
- Performing testing, validation, equipment qualifications, and data analysis. Make recommendations for changes in equipment, products, or test methods.
- Reviewing manufacturing planning for appropriate quality requirements.
- Preparing appropriate documentation for critical quality control points throughout the manufacturing processes. Ensures documentation contains the necessary criteria and provisions for effective inspection and testing.
- Compiling and analyze data related to quality and manufacturing issues and initiate CAPA. Monitor and verifies the completion and effectiveness of corrective actions.
- Performing investigations and prepare reports for customer complaints.
- Conducts or participates in ISO audits, internal audits, and Customer audits.
- Preparing and review Quality Technical Agreements and supplier evaluation surveys.
- Supporting process/product improvement projects, product design reviews, products and raw materials non-conformance investigations, review and disposition.
- Performing ISO, GDP, and technical training.
- Interfacing at all organizational levels within the company, customers, and suppliers.
- Acting as direct quality liaison with Engineering, Manufacturing, Marketing and customers.
- May serve as Lab Safety Coordinator in conjunction with the company's Hazard Communication Program.
- Bachelor's degree in Engineering or Life Science.
- 7+ years Quality Engineering and/or Manufacturing Engineering experience.
- Demonstrates working knowledge of ISO 9001 quality system and/or FDA 21 CFR 820 quality regulations.
- Knowledge of Investigative / problem solving tools and scientific/technical investigations.
- Experience/training in quality planning, CAPA, quality auditing, root cause analysis, and statistical data analysis.
- Good interpersonal, verbal communication and writing skills. Able to express thoughts and concepts at both technical and administrative level.
- Demonstrated ability to proficiently review technical and quality requirements, deal with nonverbal symbolism (i.e., formulas, scientific equations, graphs, etc.).
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