Quality Engineer (Consultant1099) – 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

• Bachelors or Masters 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.