PURPOSE AND SCOPEAs a key member of the Software Quality Group, the incumbent will support the process development activities related to the design, development, or reliability of Fresenius Medical Care’s products.
PRINCIPAL DUTIES AND RESPONSIBILITIESFamiliarity with the FDA’s Quality System Regulation (QSR) 21 CFR Part 820.Understanding of ISO13485 (Medical devices Quality management systems) and ISO 14971 (Application of risk management to medical devices)Knowledge of QMS principles and practicesExpertise in risk management processes, including hazard analysis, risk assessment, risk controlUnderstanding of design control processes, including design input, design output, design verification, design validation, design transfer, and design changesStrong problem solving and analytical skills.
Lead major efforts, or phases of projects, to resolve Software Quality-related problemsSupport the product development teams in the adoption and use of best practices, Quality tools, and Software Design Control methodologiesDevelop and execute systems level and functional area testsMonitoring and developing software reliability improvements to existing & new designStrong analytical and problem-solving skills, ability to multitask in an environment with changing prioritiesSupport Software Quality System sub-systems as directed by senior management, i.
e. CAPA, Internal Audits, etAssist with various projects as assigned.Other duties as assigned.EDUCATIONBachelor's Degree required;
Advanced Degree desirablesREQUIREMENTS7+ years related Software Quality Assurance / Quality Engineering experience.4+ years experience with embedded software or real-time devices / systems level testing required2+ years experience leading and managing software quality teamsASQ Certification(s) a plus, Six Sigma experience highly desirableWorking knowledge of FDA Quality System Regulation 21 CFR Part 820 and ISO13485 required.
Excellent verbal communication and technical writing skillsAbility to interface with multiple groups in the organization.
Experience with structured programming languages and scripting desired
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