Quality Engineer

We are seeking a dedicated professional to join our team. This role involves maintaining and updating quality management processes to meet Quality/Regulatory requirements, specifically within the medical device sector. The ideal candidate will collaborate closely with the product team to enhance product and process quality, ensuring compliance with FDA and EUMDR standards.

• Work with the quality management team to maintain and update quality management processes and activities to meet Quality/Regulatory requirements.
• Collaborate with the product team to maintain and improve product and process quality for FDA & EUMDR Class II medical devices.
• Participate in ISO & EUMDR audits and FDA inspections.
• Responsible for QA-related internal training.
• Support design inputs/outputs, design reviews, verification & validation (V&V), and design transfer to manufacturing.
• Ensure design controls comply with applicable regulations throughout the lifecycle.
• Support risk management activities per ISO 14971, including hazard analysis and risk assessments.
• Support manufacturing process controls, change control, and production quality.
• Investigate nonconformances and support root cause analysis and CAPA activities under the guidance of the Quality Manager.

• BS/BA or advanced degree in a related discipline.
• 3-5 years of experience in Quality Management, preferably with a manufacturer of medical devices including software.
• Strong knowledge of compliance with FDA QMSR, ISO 13485, and EUMDR.
• Successful experience in external audits and inspections.