Quality Engineer

Key Responsibilities

• Maintain and improve the Quality Management System (QMS) to ensure compliance and operational effectiveness
• Manage QMS processes including Audits, CAPA, Document Control, and Training
• Analyze quality data, identify improvement opportunities, and support corrective actions
• Prepare for and support external audits and inspections
• Collaborate cross-functionally on quality planning, risk management, validation, and training initiatives

Required Education & Experience

• Bachelor’s degree in Engineering, Science, Manufacturing, or related field
• 5+ years of experience in Quality Systems, Compliance, or Auditing within a regulated environment
• EU MDR

Knowledge, Skills, & Abilities

• Strong knowledge of quality systems, regulatory compliance, and risk management
• Experience supporting audits and maintaining compliant processes
• Strong communication, analytical, and problem-solving skills
• Proficiency with Microsoft Office applications

Preferred Qualifications

• Project management experience
• Lead Auditor or Quality Auditor certification
• Experience with software lifecycle or validation requirements
• Familiarity with international regulatory standards

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off