Qualifications

• Bachelor's degree in Science, Engineering, or related field; advanced degree preferred.
• Minimum 3 years experience in quality engineering and risk management.
• Strong understanding of FDA regulations, ISO 13485, and international quality standards.
• Familiar with risk management techniques (ISO 14971) and validation methodologies.
• Proficient in quality and statistical analysis tools (e.g., Minitab).
• CQE, CQA, or Six Sigma certification preferred.
• Experience with medical devices (Class I/II) or combination products is a plus.

Responsibilities

• Conduct quality engineering activities in compliance with FDA Regulations and ISO 13485.
• Lead quality assurance initiatives to enhance engineering and technical knowledge.
• Develop quality assurance programs to ensure products meet applicable requirements.
• Collaborate on NCR investigations and propose corrective actions to improve quality.
• Ensure the highest quality in product design, testing, and risk analysis processes.
• Participate in CAPA management and deliver quality engineering projects.
• Analyze data trends to support management decisions and quality improvements.

Benefits

• Full-time position with a focus on hands-on, collaborative work environment.
• Ownership of diverse quality assurance responsibilities in the medical device sector.
• Opportunity to directly influence product safety and compliance standards.
• Working alongside cross-functional teams to tackle complex quality challenges.