Quality Engineer (Consultant/1099) – Project Management Focus

About the Role

MB&A is expanding its network of high-impact consultants to support strategic quality and project leadership initiatives for leading medtech 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 execution. This role is ideal for consultants who can both lead quality initiatives and personally drive deliverables in regulated environments.

Key Responsibilities

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

Qualifications

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

Certifications (Preferred)

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

Why MB&A?

At MB&A, we partner with experienced consultants who thrive in complex, regulated environments and bring both leadership presence and execution strength. Our consultants work on high-impact engagements where quality leadership directly influences product success and patient outcomes.