Job Description:
Pay Range: $64.71hr - $69.71hr
The Principal Quality Engineer is responsible for developing, implementing, and maintaining quality systems and processes for In Vitro Diagnostics (IVD) products in compliance with applicable regulatory and quality standards. This role partners closely with cross-functional teams to ensure quality is embedded throughout the product lifecycle, from design and development through post-market activities. Responsibilities: Develop, implement, and maintain quality systems in compliance with FDA 21 CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971, and other applicable regulations Conduct hazard analysis and risk assessments throughout the IVD product lifecycle in accordance with ISO 14971. Lead internal and external audits, including preparation, execution, follow-up, and corrective actions. Oversee CAPA processes, non-conformance investigations, and d...