Quality Engineer III – Shift B

About the role

As a Quality Engineer III on Shift B, you will uphold the Quality Policy by executing sound quality practices and maintaining an effective quality system. You will ensure compliance with all regulations governing product quality and patient safety, while guiding your team to meet training and compliance requirements.

Key responsibilities

• Identify and resolve complex exceptions and non‑conforming material, including root‑cause analysis and disposition.
• Lead investigations of customer complaints, document findings, and act as trainer for the GCS2 complaint‑handling software.
• Support and execute CAPA, NCEP, failure‑mode investigations and drive continuous improvement using Six Sigma, Lean and statistical methods.
• Evaluate new equipment, processes and chemicals for regulatory compliance, environmental impact and risk management.
• Develop, review and execute process validation protocols and reports, ensuring laboratory equipment is calibrated and compliant.

Required profile

• Bachelor’s degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or a related field.
• Minimum three years of experience in a quality engineering role within a regulated manufacturing environment.
• Demonstrated knowledge of QSR, ISO/MDD standards and risk‑management requirements (BS EN 14971).
• Proficiency in statistical and quality tools such as Six Sigma, Lean, Gage R&R, DOE, SPC and APQP.

Required skills

• Six Sigma and Lean methodology.
• Statistical analysis and process capability assessment.
• Process validation and verification techniques.
• Risk management (BS EN 14971).
• CAPA, NCEP and failure‑mode investigation.
• Gage R&R, Design of Experiments (DOE), Statistical Process Control (SPC).