Medical Device Quality Engineer

**Not a Technology Job**

Position Summary

A leading U.S.-based healthcare products organization is seeking Quality Engineers to support cross‑divisional remediation and quality system initiatives. This role independently establishes and maintains quality standards across a diverse portfolio of regulated products, including medical devices, commodities, OTC pharmaceuticals, and/or cosmetic products.

The Quality Engineer will evaluate manufacturing and supplier processes, recommend and implement improvements, support regulatory documentation, and ensure ongoing compliance with domestic and international quality requirements.

Key Responsibilities

• Provide quality engineering support for product development, design control activities, Design History Files (DHF), CAPA, risk management, and CE Technical Files.
• Partner with and lead suppliers on quality issues, including corrective and preventive actions (CAPA/SCAR), supplier qualifications, and quality improvement initiatives.
• Lead investigations into product, process, and supplier nonconformances and out‑of‑specification results; develop and implement effective corrective actions.
• Ensure compliance with applicable U.S. and international regulations and quality standards across assigned product lines.
• Perform quality reviews of design and supplier documentation to confirm alignment with regulatory and internal requirements.
• Develop and implement process control, validation, inspection, and testing methodologies to ensure product quality and functionality.
• Design and execute experiments to assess sources of process and product variation; apply statistical process control (SPC) tools to analyze data and drive improvements.
• Conduct product testing and analysis to minimize defects and failure rates; analyze quality trends and lead corrective actions based on data.
• Coordinate internal and third‑party laboratory testing as required.
• Create, maintain, and manage regulated product documentation, including Device Master Records (DMR); collaborate with regulatory and supplier partners on submissions such as 510(k)s and supporting documentation as needed.

Education

• Bachelor’s degree in Engineering, Science, Mathematics, or a related technical field.

Required Experience

• Minimum of 2 years of experience in Quality Engineering and/or related engineering roles within a regulated environment.

Required Skills & Knowledge

• Ability to work independently with minimal supervision while knowing when to escalate issues.
• Strong time management skills with the ability to prioritize and manage multiple projects.
• Demonstrated problem‑solving skills using structured, analytical, and data‑driven approaches.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Intermediate Excel skills (e.g., formulas, tables, charts, conditional formatting).
• Working knowledge of relevant quality and regulatory standards such as 21 CFR 820 and ISO 13485.
• Willingness to travel up to 15% as needed.

Preferred Qualifications

• Industry experience within medical devices, pharmaceuticals, cosmetics, or similarly regulated product environments.