Quality Engineer (Consultant/1099) – Project Management Focus
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AI Summary
This is a remote position.
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.
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