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.