Job Description

Position Summary:

The Quality Engineer (QE) will collaborate with manufacturing and cross-functional teams to address technical challenges, manage process changes, and drive quality improvements. Key responsibilities include analyzing data, supporting risk management, optimizing processes, and contributing to quality system deliverables such as APQP, FMEA, CAPA, and process validation (IQ/OQ/PQ). The QE will also track performance metrics, work with teams to resolve issues, and ensure compliance with quality and regulatory standards.

Essential Functions:

• Analyze data using statistical methods to support decision-making.
• Drive continuous improvement using quality tools (Pareto, DOE, SPC, GRR, etc.).
• Assist with QMS deliverables (APQP, CAPA, risk analysis, etc.).
• Plan and conduct process/equipment validations (IQ/OQ/PQ).
• Monitor engineering processes and products for compliance with quality standards.
• Recommend modifications for quality improvements and optimized production.
• Collaborate with teams to address production and quality issues.
• Ensure adherence to QMS procedures for quality and regulatory compliance.

Qualifications:

• Education : Bachelor's degree in engineering, life sciences, or technical discipline.
• Experience : 3+ years in quality assurance in a medical device/pharmaceutical manufacturing environment.
• Skills : Knowledge of statistics, Minitab, process capability, DOE, statistical process control, and quality management systems (FDA, ISO 13485). Strong analytical, technical writing, and communication skills.
• Preferred : ASQ Certified Quality Engineer (CQE), ISO 14971, SPC, Lean Six Sigma training, experience with FMEA, process validations, and electronic QMS systems.

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