Quality Engineer

In this position, you will help develop, implement, and maintain the Quality Management System (QMS) to ensure our medical devices consistently meet quality and regulatory requirements. You will work closely with engineering and manufacturing teams to support product development, quality control, verification testing, and continuous improvement. This role includes ownership of internal and external product testing, quality documentation, and engineering support throughout the product lifecycle.

• Maintain and improve the company's Quality Management System (QMS) in accordance with ISO 13485 and FDA Quality System Regulation (QMSR).
• Support product development by ensuring compliance with design control and quality system requirements.
• Create and maintain quality documentation, including Design History Files (DHF), change control documentation, and engineering records.
• Develop, execute, and document verification and validation (V&V) testing.
• Plan and perform internal bench testing and engineering testing for product development and quality verification.
• Coordinate external testing with accredited laboratories for electrical safety, EMC, environmental, transportation, and other applicable testing.
• Write and maintain engineering test protocols, reports, and supporting quality documentation.
• Analyze test results, investigate failures, and support root cause analysis and corrective actions.
• Participate in internal audits, CAPA activities, nonconformance investigations, and continuous improvement initiatives.
• Collaborate with engineering and manufacturing teams to ensure product quality throughout development and production.
• Support production quality activities, including inspection processes and manufacturing quality improvements.

• Bachelor's in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 3+ years of experience in medical device quality engineering or quality management.
• Familiarity with ISO 13485, FDA QMSR, Design Controls, Design History Files (DHF), and change control processes.
• Experience performing bench testing, verification testing, or product validation.
• Experience writing engineering test protocols and technical reports.
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication skills.

• Familiarity with ISO 14971 risk management principles.
• Experience with CAPA, internal audits, and nonconformance investigations.
• Experience working with external testing laboratories.
• Experience supporting manufacturing quality and inspection activities.
• Knowledge of medical device verification and validation processes.

• Ability to work at a computer workstation for extended periods
• Occasional lifting of up to 25 lbs (test equipment, prototypes)
• Ability to work in a lab environment, including use of hand tools and test instrumentation

This role is based primarily in an office/lab setting, with occasional collaboration across manufacturing or production areas.