Medical Device Quality Engineer

**Not a Technology Job**Position SummaryA 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 ResponsibilitiesProvide 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.EducationBachelor’s degree in Engineering, Science, Mathematics, or a related technical field.Required ExperienceMinimum of 2 years of experience in Quality Engineering and/or related engineering roles within a regulated environment.Required Skills & KnowledgeAbility 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 QualificationsIndustry experience within medical devices, pharmaceuticals, cosmetics, or similarly regulated product environments.