Quality Engineer – Project Management Focus

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🕒 February 2

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MB&A

WebsiteLinkedInAll Job Openings

2 - 10 employees

Founded 2019

🏥 Healthcare

🎯 Recruiter

💼 Consulting

Healthcare • Recruitment • Consulting

MB&A is a boutique recruiting and consulting firm focused on the medical device manufacturing industry. They provide talent acquisition, staffing, and recruiting services as well as quality and regulatory consulting including quality system audits, audit and compliance services, management review preparation, remediation support, Quality Due Diligence, operations and engineering support, SaMD/SiMD quality systems management, start-up partnerships, and project management. MB&A leverages over 20 years of experience conducting quality system audits for medical device manufacturers and suppliers worldwide and partners with machine shops for manufacturing and sourcing support.

📋 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.

🎯 Requirements

• 10+ years of hands-on Quality Engineering experience in the medical device or biotech industry • Demonstrated project management experience with cross-functional stakeholder engagement • Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR , and related regulations. • Certified Quality Engineer (CQE) – Required • Project Management Professional (PMP) – Preferred • Medical Device Reporting (MDR) / Complaint Handling Training • Experience supporting global quality processes such as CAPA, complaints, and audit readiness.

🏖️ Benefits

• Health insurance • Flexible work hours • Professional development opportunities