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Medical Device Quality Assurance Specialist

1 month ago

Reston, Virginia, United States HireMinds Full time
Job Title: Dev Quality Engineer II

HireMinds is proud to partner with a leader in medical device innovation, focusing on improving healthcare through cutting-edge technology and personalized solutions.

We're seeking a Dev Quality Engineer II to join the New Product Development team to ensure the quality and safety of their medical devices throughout the product development lifecycle. You'll work with cross-functional teams to maintain compliance with industry regulations and meet customer expectations.

Key Responsibilities:

  • Collaborate with development teams to implement quality standards
  • Lead risk management activities, including assessments and mitigation strategies
  • Review and approve product/process validation activities
  • Conduct design and process failure mode and effects analysis (DFMEA/PFMEA)
  • Develop test methods, inspection plans, and quality control procedures
  • Ensure compliance with FDA, ISO, ITAR, and other relevant standards
  • Investigate non-conformances and implement corrective actions
  • Support design teams in addressing quality concerns and improving manufacturability
  • Assist in supplier quality management and audits
  • Maintain quality documentation and contribute to regulatory submissions

Qualifications:

  • Bachelor's degree in engineering (biomedical, mechanical, or related field) or equivalent experience
  • 3-5 years of quality engineering experience, preferably in medical devices
  • Knowledge of medical device regulations (FDA 21 CFR Part 820, ISO 13485, ISO 14971)
  • Experience with ITAR-covered parts development
  • Proficiency in quality tools (FMEA, CAPA, statistical analysis)
  • Quality certifications (e.g., ASQ Certified Quality Engineer) preferred
  • Strong problem-solving, analytical, and communication skills
  • Experience with additive manufacturing is a plus

Benefits:

  • Competitive salary ($75,000 $100,000, based on qualifications and experience)
  • Annual performance-based bonus
  • Comprehensive benefits (medical, dental, vision, disability, life, 401k)
  • Paid time off: Flex Time, Sick Leave, FAMLI Leave, Parental Leave, 9 holidays/year
  • Educational assistance and supplemental health/life plans

Join a collaborative, innovative environment with opportunities for professional growth and contribute to the development of life-saving medical devices.