Quality Engineer

About the position

The Quality Engineer will play a key role in maintaining and improving the quality management system (QMS) for our medical device products. You will be responsible for ensuring product compliance with FDA regulations, ISO 13485 standards, and other applicable regulatory requirements. The ideal candidate will have strong experience in the medical device industry and a solid understanding of quality control processes, inspections, and testing methods.

Responsibilities

• Support development, implementation and maintenance of the Quality Management System (QMS)
• Support internal and external audits to assess compliance and identify opportunities for improvement
• Support product development processes with quality planning and risk management strategies
• Conduct root cause analysis and implement corrective and preventative actions (CAPA)
• Perform product inspections, validation, and verification to ensure product quality
• Assist in the development and review of product documentation, including device master record (DMR), device history records (DHR), and technical files
• Provide support for product testing and qualification activities (e.g. design verification, validation, and stability testing)
• Work with suppliers and vendor to ensure the quality for raw materials and components
• Maintain records and reports of quality metrics, trends and performance for continuous improvement initiatives

Requirements

• Bachelors degree in engineering or related field
• 5+ years of experience in a Quality Engineering role within a medical device industry
• Familiarity with FDA regulations, ISO 13485, and other relevant quality standards
• Experience with risk management tools (e.g., FMEA, risk assessments)
• Knowledge of statistical methods and process control techniques
• Strong problem-solving skills with the ability to conduct root cause analysis and implement corrective actions
• Ability to work independently and collaboratively in a small team environment

Nice-to-haves

• Experience with design controls and validation processes for medical devices
• Certification in Quality Engineering (CQE) or other relevant certification is a plus
• Familiarity with regulatory submissions and audits