Quality Engineer – Process Validation & QA

About the role

The Quality Engineer ensures that products, processes, and quality records meet established standards and regulatory requirements. Working closely with cross‑functional teams, the role drives continuous improvement and supports customer projects from validation through production.

Key responsibilities

• Modify testing methods and inspection work instructions to achieve cost‑effective, high‑quality outcomes.
• Provide statistical analysis for quality improvement and cost savings.
• Investigate product and process issues, recommend corrective actions, and update the Quality Management System.
• Perform internal quality audits and report findings.
• Program and operate CMM equipment using Zeiss Calypso software.
• Plan and execute Gage R&R, DOE, IQ, OQ, and PQ activities for customer projects.
• Conduct capability studies, calculate Cpk, and present results to customers.
• Make day‑to‑day product acceptability decisions and manage deviations.
• Administer the online Statistical Process Control (SPC) system, create CTQ standards, and troubleshoot system issues.

Required profile

• Strong collaborative mindset with ability to work across manufacturing, engineering, and customer teams.
• Experience in quality assurance, process validation, and regulatory compliance.
• Proven analytical skills for data‑driven decision making.
• Excellent communication skills for presenting findings and recommendations.

Required skills

• CMM programming – Zeiss Calypso
• Statistical Process Control (SPC) administration
• Gage R&R methodology
• Design of Experiments (DOE)
• Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
• Capability studies and Cpk analysis
• Internal quality audits
• Data acquisition and statistical analysis

What we offer

• Opportunity to lead quality initiatives on high‑impact customer projects.
• Collaborative environment with cross‑functional teams.
• Professional development in advanced quality engineering tools.