Sr. Quality Engineer

Quality Management System Specialist

In this role you ensure the integrity of the Quality Management System and drive quality excellence across the product lifecycle. You partner with cross-functional teams to maintain compliance, lead process improvements, and support safe and effective medical devices. You will own root-cause investigations, CAPA, change control, and validation activities to prevent issues and improve outcomes. This position offers meaningful impact on patient safety and product quality within a mission-driven organization.

Compensation / Benefits

• healthcare
• 401(k) plan
• tuition reimbursement

Responsibilities

• Lead quality system activities (nonconformances, CAPA investigations, complaint investigations and trend analysis)
• Handle change control, validation activities, quality inspections, MRB activities, and internal audits
• Conduct root cause investigations and implement corrective actions
• Collaborate with Engineering, Manufacturing, and other teams to mitigate quality risks
• Ensure compliance with FDA regulations, ISO 13485, and internal quality standards
• Audit processes, suppliers, and materials to meet quality requirements
• Drive continuous improvement and quality enhancement projects
• Analyze quality data and recommend process improvements

Key requirements

• Bachelor's degree in Engineering, Quality, Life Sciences, or related field
• 6+ years of Quality Engineering experience in a regulated manufacturing environment
• Medical Device industry experience
• Professional quality certification (ASQ CQE, CQA, or equivalent)
• Strong knowledge of QMS, CAPA, Root Cause Analysis, Change Control, Validation, Internal Auditing, Complaint Handling

• Cross-functional collaboration
• Communication
• Problem-solving
• Quality Management Systems (QMS)
• CAPA
• Root Cause Analysis