Overview
Quality Assurance Manager Jobs in Greater Boston at X4 Technology
Title: Quality Assurance Manager
Company: X4 Technology
Location: Greater Boston
🚀 Operations Quality Manager | Medical Devices | Manufacturing Excellence | $170,000+
Are you a hands-on Quality leader who thrives on driving operational excellence in highly regulated manufacturing environments?
An exciting opportunity has arisen for an experienced Operations Quality Manager with 13285 Experience to take ownership of manufacturing quality within an innovative, complex medical device organisation. This is a highly visible leadership role where you'll have the autonomy to influence quality strategy, drive continuous improvement, and shape quality culture across the business.
Why this role stands out:
✅ Lead all manufacturing quality activities across production operations
✅ Be the key decision-maker for product quality, risk management, non-conformances, and product release
✅ Drive Lean and Six Sigma initiatives to improve quality, efficiency, yield, and process capability
✅ Partner closely with Manufacturing, Engineering, Supply Chain, and Operations leaders
✅ Lead and develop a team of Quality Engineers, QC professionals, and inspectors
✅ Play a critical role in audit readiness, regulatory compliance, and quality system effectiveness
What we're looking for:
🔹 Bachelor's Degree in Engineering (Mechanical, Electrical, or related discipline)
🔹 8+ years' experience within medical device manufacturing quality
🔹 Proven experience leading Manufacturing Quality functions and shop-floor quality execution
🔹 Strong knowledge of ISO 13485, CAPA, NCR/MRB processes, and risk-based quality systems
🔹 Experience managing Quality Engineers and QC teams
🔹 Confidence making independent quality decisions in fast-paced manufacturing environments
Highly desirable:
⭐ Experience with complex, low-volume medical devices such as radiation therapy systems, imaging equipment, MRI, CT, X-ray, or similar technologies
⭐ Lean Six Sigma certification
⭐ High-mix, low-volume manufacturing experience
⭐ Proven success driving quality culture transformation and continuous improvement initiatives
This is an excellent opportunity for a quality professional who wants to make a tangible impact on patient-focused technology while leading meaningful operational improvements across a sophisticated manufacturing environment.
📩 Interested in learning more? Apply now or send a confidential message for further details.
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