remote
QA Engineer II - Operational Excellence PPI Lead - Thermo Fisher Scientific
QA Engineer
QA Engineer II focused on operational excellence, leading process performance improvement initiatives, ensuring GMP compliance, and driving root‑cause analysis and statistical validation of manufacturing processes.
About the role
Key Responsibilities
- Lead Process Performance Improvement (PPI) projects to enhance manufacturing efficiency and product quality.
- Conduct root‑cause investigations, data analysis, and statistical evaluations to identify and mitigate process deviations.
- Develop, execute, and maintain validation protocols and GMP‑compliant documentation for new and existing processes.
- Collaborate with cross‑functional teams—including production, engineering, and quality—to implement corrective actions and continuous‑improvement initiatives.
- Monitor key performance indicators, generate reports, and present findings to senior leadership.
Requirements
- Bachelor’s degree in Engineering, Science, or related field with 2–4 years of QA or process‑improvement experience in a GMP environment.
- Proficiency in statistical analysis tools (e.g., Minitab, JMP) and strong data‑driven problem‑solving skills.
- Demonstrated ability to lead PPI projects, perform root‑cause analysis, and develop validation documentation.
- Excellent communication and teamwork skills, with the ability to influence cross‑functional stakeholders.
- Knowledge of regulatory standards (FDA, ISO) and experience with continuous‑improvement methodologies such as Lean or Six Sigma is a plus.
Skills
process improvement