Quality Engineer – Project Management Focus

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🕒 February 2

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MB&A

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2019

⚕️ Healthcare Insurance

🎯 Recruiter

💊 Pharmaceuticals

Healthcare Insurance • Recruitment • Pharmaceuticals

MB&A is a boutique recruiting and consulting firm specializing in talent acquisition and business consulting for the medical device manufacturing sector. With over 20 years of experience, MB&A offers services including staffing, quality system audits, and regulatory support for software as a medical device (SaMD) products. The company prides itself on its deep industry expertise and commitment to connecting organizations with the right talent to enhance operational efficiency and meet regulatory standards.

📋 Description

• 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

• 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.

🏖️ Benefits

• 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.