Job Overview
Pay Range: $64.71hr - $69.71hr
* The Principal Quality Engineer is responsible for developing, implementing, and maintaining quality systems and processes to ensure compliance with regulatory standards for medical device and in vitro diagnostic products.
* This role focuses on design control, risk management, regulatory compliance, and continuous improvement across the product lifecycle.
* The candidate will collaborate with cross‑functional teams, lead audits, and support regulatory submissions while ensuring product safety and quality.
Requirement/Must Have
* Strong experience with quality systems and regulatory compliance for medical devices or IVD products.
* Hands‑on experience with design controls and risk management processes.
* Experience conducting audits, CAPA management, and non‑conformance investigations.
* Strong understanding of regulatory standards and quality frameworks.
* Experience managing post‑market activities and incident reporting.
* Ability to lead cross‑functional teams and drive quality initiatives.
Experience
* 8+ years of experience in medical devices or in vitro diagnostics design and development.
Responsibilities
* Develop, implement, and maintain quality systems in compliance with regulatory standards.
* Conduct hazard analysis and risk assessments throughout the product lifecycle.
* Lead internal and external audits, including preparation and follow‑up activities.
* Manage CAPA processes, non‑conformance investigations, and deviations.
* Collaborate with product development teams to integrate quality requirements.
* Review and approve design control documentation and risk management files.
* Assess and qualify suppliers across the product lifecycle.
* Establish and maintain Design History Files.
* Monitor and analyze quality metrics to identify improvement opportunities.
* Support regulatory submissions and product approvals.
* Manage complaint handling and post‑market incident activities.
* Drive continuous improvement initiatives in quality and risk management processes.
* Stay current with evolving regulatory requirements and industry trends.
* Update internal processes, policies, and training materials as needed.
* Perform additional duties as assigned.
Should Have
* Experience working in regulated environments and with IVD products.
* Strong analytical mindset with attention to detail.
* Experience applying medical device regulations and standards.
* Strong leadership and team collaboration skills.
* Ability to influence and drive organizational change.
* Strong communication, presentation, and problem‑solving skills.
* Ability to manage projects and priorities in a dynamic environment.
Skills
* Quality management systems and compliance.
* Design controls and risk management.
* CAPA and audit management.
* Regulatory standards and documentation.
* Data analysis and continuous improvement.
Qualification And Education
* Bachelor’s degree in a relevant field.
* ASQ Certification is preferred.
* Regulatory Affairs Certification is preferred.
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