Quality Engineer (Consultant/1099) – Project Management Focus

This is a remote position.

MB&A is expanding its network of high-impact consultants to support strategic quality and project leadership initiatives for leading med-tech and life sciences companies. We are seeking senior Quality Engineers who bring executive-level project leadership, strong stakeholder presence, and deep hands-on Quality Engineering expertise.

This role is ideal for consultants who can lead quality initiatives while also driving hands-on execution in highly regulated environments.

• Provide project leadership for quality initiatives, serving as a trusted partner to client stakeholders and leadership teams.
  
• Lead and execute quality engineering activities across the product lifecycle, from development through post-market support.
  
• Support implementation, validation, and optimization of electronic Quality Management Systems (eQMS).
  
• Develop and maintain procedures, SOPs, and work instructions aligned with FDA, ISO 13485, and EU MDR requirements.
  
• Perform risk management activities, root cause analysis, and CAPA investigations using structured methodologies.
  
• Support manufacturing transfers, supplier transitions, and design transfer activities.
  
• Lead audit readiness initiatives and support FDA, ISO, BSI, and other regulatory inspections.
  
• Develop quality metrics, dashboards, and reporting to support leadership decision-making.
  

Requirements

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Engineering Science, or a related discipline.
  
• 10+ years of hands-on Quality Engineering experience in the medical device or biotech industry.
  
• Demonstrated project management experience with cross-functional stakeholder engagement.
  
• Experience supporting medical device product development, design transfer, and technical documentation.
  
• Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and related regulations.
  
• Experience working with QMS or eQMS platforms.
  
• Experience supporting global quality processes such as CAPA, complaints, and audit readiness.
  
• Certified Quality Engineer (CQE) – Required
  

• Project Management Professional (PMP)
  
• Medical Device Reporting (MDR) / Complaint Handling Training
  
• CQA, RAPS, or related Quality/Regulatory certifications
  

Benefits