About this opportunity
Pop-Up Talent lists this Senior Quality Assurance Engineer, Medical Devices opportunity in charlottesville, va, Virginia. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Senior Quality Assurance Engineer – Medical Devices Charlottesville, VA 22911
Department: Quality Assurance / Regulatory Affairs
Reports To: Director, Quality and Design Assurance Engineering
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 capabilities
The 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 programs
Participate in design verification, design validation, risk management, process validation, packaging validation, sterilization validation, and design transfer activities
Develop, execute, and review validation and qualification protocols and reports, including IQ/OQ/PQ activities
Ensure compliance with applicable FDA regulations, ISO standards, company procedures, and other regulatory requirements
Support and/or lead CAPA, complaint investigations, nonconformance investigations, root cause analysis, and corrective action activities
Evaluate product and process changes and assess impact on product quality, validation status, and regulatory compliance
Collaborate with R&D, Manufacturing, Regulatory Affairs, Supply Chain, and Operations teams to drive quality objectives and support product launches
Support supplier quality activities including supplier qualification, audits, incoming quality issues, and material discrepancy resolution
Utilize statistical analysis and data-driven decision-making to evaluate process capability, quality trends, and product performance
Participate in quality metrics reviews and continuous improvement initiatives to improve QMS effectiveness and operational performance
Support internal and external audits and assist in maintaining an inspection-ready quality system
Assist with or lead implementation of quality system improvements, software tools, and process optimization projects
Provide technical quality guidance to cross-functional teams and, at the senior level, mentor less experienced team members
Perform other duties as assigned
EDUCATION AND EXPERIENCE:
Required
Bachelor's degree in Engineering, Science, or a related technical discipline
For Quality Assurance Engineer
At least 0 to 3 years of quality, manufacturing, or engineering experience
Experience in a regulated manufacturing environment preferred
Knowledge of FDA, ISO 13485, CAPA, validation, and quality systems preferred
For Senior Quality Assurance Engineer
At least 6+ years of quality or manufacturing engineering experience
Experience in medical devices or another highly regulated industry required
Demonstrated experience leading CAPAs, risk management activities, validation programs, supplier quality initiatives, and quality improvement projects
Prior experience mentoring or providing technical leadership preferred
PREFERRED QUALIFICATIONS:
Medical device industry experience
Supplier quality experience
ASQ Certified Quality Engineer (CQE) or other ASQ certification
Lean Six Sigma certification or experience
Experience with statistical analysis, process capability studies, and quality improvement methodologies
We are an equal opportunity employer, and we are an organization that values diversity. We welcome applications from all qualified candidates, including minorities and persons with disabilities.
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Who can apply
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