Project Quality Engineer

About the role

Tegra Medical is seeking a Project Quality Engineer to lead quality initiatives during product transfers, process development, and qualification activities for medical device projects. You will ensure compliance with customer specifications, company standards, and regulatory requirements while supporting a fast‑paced manufacturing environment.

Key responsibilities

• Lead quality activities for product transfers and new process implementations.
• Develop and execute qualification and validation plans, including pFMEA, IQ, OQ, PQ, and TMV.
• Perform statistical analyses, Gage R&R studies, capability analyses, and other process improvement tasks.
• Conduct risk assessments, track mitigation actions, and drive corrective actions.
• Investigate technical and quality issues, determine root causes, and support resolution.
• Collaborate with customers, suppliers, Operations, Engineering, and cross‑functional teams.
• Create measurement work instructions and quality alerts for new projects.

Required profile

• Bachelor’s degree in engineering (Mechanical or Industrial preferred).
• Approximately 4 years of experience in Quality Engineering, preferably in medical device or regulated manufacturing.
• Strong knowledge of GMP, FDA regulations, SOPs, and quality standards.
• Experience with process validation, risk assessment, and documentation.
• Excellent analytical, problem‑solving, organizational, and communication skills.
• Fluent written and spoken English.

Required skills

• Process validation
• Good Manufacturing Practices (GMP) and FDA requirements
• Standard Operating Procedures (SOPs) and quality standards
• pFMEA, Control Plans, SPC, capability analysis, Gage R&R
• Six Sigma tools
• Statistical analysis using Minitab
• Microsoft Office suite