Principal Quality Engineer

Overview

This position ensures product lifecycle activities—spanning design, development, production, distribution, and service—comply with applicable procedures, standards, and regulations. Acting as a technical leader and mentor, the role provides project or program-level guidance, applies quality tools and risk management principles, and promotes continuous improvement across cross-functional teams. The position also supports audits, leads quality initiatives, and may supervise other Quality Engineers.

$/yr - $/yr

• Lead and review quality documentation throughout the product lifecycle.
• Advise teams on compliance with regulations, standards, and procedures—including those related to cybersecurity and privacy.
• Ensure product quality and complete documentation before approvals.
• Drive implementation of design controls and product realization requirements.
• Lead or support new product development, design changes, and investigations.
• Apply statistical and quality tools to evaluate results, risk analyses, and validations.
• Guide corrective/preventive actions (CAPAs) and support audit readiness.
• Approve change orders related to product performance, processes, and labeling.
• Mentor Quality Engineers and contribute to training and knowledge sharing.
• Lead cross-functional projects and quality system improvements.

• Bachelor’s degree (or equivalent) in engineering or science.
• Minimum 9 years of experience in medical devices, pharmaceuticals, diagnostics, or clinical laboratories; or 8 years with an advanced degree.
• Strong foundation in engineering/science principles across R&D, quality control, manufacturing, and design.
• Proven ability to apply technical and engineering problem-solving skills to complex issues.
• Deep knowledge of domestic and international regulatory and quality standards.
• Proficient in quality management methods and statistical techniques (e.g., Lean, Six Sigma).
• Understanding of risk-based approaches to compliance, data analysis, and decision-making.
• Having experience - being a true document owner of risk management documentation
• PFMEAs - owning and changing/updating Risk documentation

• ASQ Certified Quality Engineer (CQE).
• Lean or Six Sigma certification.

• Mid-Senior level

• Full-time

• Quality Assurance
• Medical Equipment Manufacturing