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 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. Key Responsibilities 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 Qualifications 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 Certifications (Preferred) Project Management Professional (PMP) Medical Device Reporting (MDR) / Complaint Handling Training CQA, RAPS, or related Quality/Regulatory certifications Benefits 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.