Senior Quality Assurance Engineer

Yesterday

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Precise Solutions

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Female business enterprise certified company. Founded in 2000

IT Consulting • Staffing Solutions

51 - 200

Description

• Represent QA on cross-functional Software as a Medical Device (SaMD) and Digital Health Software teams • Execute Quality System requirements to ensure products compliance with Medical Device Regulations • Author, review, and approve project documentation associated with SDLC and design control requirements • Create and maintain QMS documents for SaMD’s and Digital Health Software Products

Requirements

• Bachelor’s degree or equivalent in sciences, engineering or other technical/scientific area • 5+ years of industry experience in Quality Assurance, Development or healthcare related field, or 3+ years with Master’s degree • Experience in Medical devices, specifically development of Software Medical Devices is desired • Strong understanding of regulations affecting software medical devices (IEC 62304, 21 CFR 820.30, EU MDR) • Experience with creation and maintenance of QMS documents for medical devices

Benefits

• Competitive compensation packages • Great salaries • Health insurance • Paid time off • Employer-based 401k contributions • Dental and vision insurance