Senior Quality Assurance Engineer, Medical Devices

Senior Quality Assurance Engineer – Medical DevicesCharlottesville, VA 22911Department: Quality Assurance / Regulatory AffairsReports To: Director, Quality and Design Assurance Engineering

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100% onsite, Relocation assistance provided
POSITION SUMMARY:MicroAire is seeking talented Quality Engineers at multiple experience levels. Candidates may be considered for either a Quality Assurance Engineer or Senior Quality Assurance Engineer position based on qualifications, experience, and demonstrated capabilitiesThe Quality Assurance Engineer supports and leads quality engineering activities associated with new product development, sustaining engineering, supplier quality, and Quality Management System (QMS) initiatives within a regulated medical device environment. This role partners with cross-functional teams to ensure products, processes, and systems meet quality, regulatory, and customer requirements while supporting innovation, operational excellence, and continuous improvement. Depending on experience and qualifications, the successful candidate may be hired at the Quality Assurance Engineer or Senior Quality Assurance Engineer level
ESSENTIAL DUTIES AND RESPONSIBILITIES:Support and/or lead quality engineering activities related to new product development, design control, and sustaining engineering programsParticipate in design verification, design validation, risk management, process validation, packaging validation, sterilization validation, and design transfer activitiesDevelop, execute, and review validation and qualification protocols and reports, including IQ/OQ/PQ activitiesEnsure compliance with applicable FDA regulations, ISO standards, company procedures, and other regulatory requirementsSupport and/or lead CAPA, complaint investigations, nonconformance investigations, root cause analysis, and corrective action activitiesEvaluate product and process changes and assess impact on product quality, validation status, and regulatory complianceCollaborate with R&D, Manufacturing, Regulatory Affairs, Supply Chain, and Operations teams to drive quality objectives and support product launchesSupport supplier quality activities including supplier qualification, audits, incoming quality issues, and material discrepancy resolutionUtilize statistical analysis and data-driven decision-making to evaluate process capability, quality trends, and product performanceParticipate in quality metrics reviews and continuous improvement initiatives to improve QMS effectiveness and operational performanceSupport internal and external audits and assist in maintaining an inspection-ready quality systemAssist with or lead implementation of quality system improvements, software tools, and process optimization projectsProvide technical quality guidance to cross-functional teams and, at the senior level, mentor less experienced team membersPerform other duties as assigned
EDUCATION AND EXPERIENCE:RequiredBachelor's degree in Engineering, Science, or a related technical discipline
For Quality Assurance EngineerAt least 0 to 3 years of quality, manufacturing, or engineering experienceExperience in a regulated manufacturing environment preferredKnowledge of FDA, ISO 13485, CAPA, validation, and quality systems preferred
For Senior Quality Assurance EngineerAt least 6+ years of quality or manufacturing engineering experienceExperience in medical devices or another highly regulated industry requiredDemonstrated experience leading CAPAs, risk management activities, validation programs, supplier quality initiatives, and quality improvement projectsPrior experience mentoring or providing technical leadership preferred
PREFERRED QUALIFICATIONS:Medical device industry experienceSupplier quality experienceASQ Certified Quality Engineer (CQE) or other ASQ certificationLean Six Sigma certification or experienceExperience with statistical analysis, process capability studies, and quality improvement methodologies
We are an equal opportunity employer, and we are an organization that values diversity. xzbcwsv We welcome applications from all qualified candidates, including minorities and persons with disabilities.
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