Senior Quality Engineer

This role supports quality activities across manufacturing programs from development through commercial production. The Quality Engineer works closely with cross-functional teams to ensure products and processes meet regulatory and quality standards, while helping drive continuous improvement and maintaining accurate documentation.

What You'll Do

• Write and review SOPs, work instructions, and other quality documents
• Help the team stay audit-ready and support internal and external audits
• Track and review quality data to spot trends and address issues early
• Manage nonconforming materials and work with suppliers on corrective actions
• Support incoming inspection and ensure materials meet requirements
• Review and approve validation activities (IQ/OQ/PQ) and process changes
• Lead investigations and CAPAs using standard root cause methods
• Partner with production as the main quality contact on the floor
• Review batch records and ensure compliance with quality standards
• Support inspections, product builds, and engineering changes
• Maintain product documentation, including design history files
• Handle product complaints and document findings
• Act as a quality SME during audits

What You Bring

• Bachelor's degree in a technical or scientific field (or equivalent experience)
• 3-5+ years in quality engineering, design assurance, or regulated manufacturing
• Familiarity with FDA/ISO quality standards (e.g., 21 CFR 820, ISO 13485)
• Understanding of risk management practices
• Experience with CAPA, nonconformance handling, and root cause analysis
• Strong attention to detail and organization
• Good communication skills and ability to work across teams
• Comfortable with Microsoft Office; experience with PLM or data tools is a plus