MB&A · 2 months ago
Quality Engineer (Consultant\/1099) – Project Management Focus
United States
Full-time
Remote
Senior Level, Lead/Staff
$100/hr - $125/hr
10+ years expMB&A is expanding its network of high-impact consultants to support strategic quality and project leadership initiatives for leading medtech and life sciences companies. They are seeking senior Quality Engineers who bring executive-level project leadership and deep hands-on Quality Engineering execution. This role involves leading quality initiatives, driving quality engineering activities, and mentoring client teams in regulated environments.
ConsultingRecruitingStaffing Agency
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
Qualification
Required
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
Preferred
Project Management Professional (PMP)
Medical Device Reporting (MDR) and Complaint Handling Training
CQA, RAPS, or other relevant Quality/Regulatory certifications
Company
MB&A
MB&A is a consulting firm built by operators, for operators.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Monica Burt
Chief Executive Officer
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