Senior Quality Assurance Engineer, Medical Devices

Senior Quality Assurance Engineer – Medical Devices

• Department:
  Quality Assurance / Regulatory Affairs
• Reports To:
  
  Director, Quality and Design Assurance Engineering

100% onsite, Relocation assistance provided

POSITION SUMMARY:

• Micro Aire 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.