Quality Engineer

About the role

The Quality Engineer will develop and manage a quality system that meets FDA and ISO requirements while supporting lean manufacturing initiatives. The role involves close collaboration with internal teams and external customers to drive continuous improvement across new and existing projects.

Key responsibilities

• Maintain compliance with the TMS Quality Management System and support internal and external audits.
• Handle customer complaints, non‑conforming events, and CAPA processes, including investigations, root‑cause analysis, and trend reporting.
• Develop and execute quality plans, inspection methods, and test equipment studies such as Gauge R&R.
• Create and approve equipment qualifications, process, cleaning, and software validations, as well as pFMEA documentation.
• Support engineering, manufacturing, NPD, and inspection teams in design, tooling, and validation activities.
• Communicate with customers on complaints, process changes, and specification clarifications.

Required profile

• Bachelor’s degree in quality, engineering, or a related field.
• Minimum 5 years of experience in a regulated manufacturing environment.
• Knowledge of GMP/ISO standards (ISO 9000/9001, ISO 13485, FDA 21CFR 820, EU/MDR).
• Certified Six Sigma Yellow/Green preferred.
• ASQ Certified Quality Engineer or Auditor preferred.

Required skills

• ISO 9001
• ISO 13485
• FDA 21CFR 820 compliance
• Six Sigma (Yellow/Green)
• ASQ Certified Quality Engineer
• CAPA management
• Root cause analysis
• Statistical and capability analysis
• Gauge R&R studies
• pFMEA documentation