Summary:

This role ensures compliance with medical device regulations and supports the product development process. The focus is on product safety, quality, and compliance while maintaining a collaborative relationship with cross-functional teams. A strong electrical engineering background will be required for this position.

Responsibilities:

• Oversee quality assurance in the product development lifecycle, including risk management, design verification, and validation.
• Ensure compliance with regulatory standards (ISO 13485, 21 CFR Part 820, etc.).
• Support the review and approval of design control documentation.
• Perform supplier quality management tasks, including audits and performance monitoring.
• Investigate product and process non-conformances; identify root causes and implement corrective actions.
• Participate in regulatory inspections and audits.
• Continuously improve quality systems and processes.

Qualifications:

• Bachelor's degree in electrical engineering or a related field.
• 3+ years of experience in quality engineering.
• Strong knowledge of design control requirements and quality system regulations.
• Strong knowledge of ISO 13485, ISO 60601, 21 CFR Part 820, and similar regulatory standards.