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.