Transforming Quality and Driving Excellence in Medical Device Manufacturing

I don’t just manage processes – I transform them in Driving Excellence in Medical Devices. Each achievement below represents my relentless drive to push boundaries, optimize systems, and deliver measurable results that impact every corner of an organization.

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🚀 96.6% Reduction in MRB (Material Review Board)

This isn’t just a number – it’s a game-changing milestone! I tackled MRB inefficiencies head-on by:

    •    Slashing material processing time to under one week

    •    Building robust monitoring systems to eliminate bottlenecks

    •    Streamlining workflows so nothing slips through the cracks

💡 This massive reduction didn’t just improve efficiency; it saved time, money, and improved product availability.

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⏱ 100% On-Time MDR Reporting

In a world where compliance can’t wait, I implemented a comprehensive complaint triage process with decision trees that guaranteed flawless reporting every single time.

    •    Zero missed deadlines

    •    Enhanced regulatory trust

    •    Strongest possible compliance posture

This 100% success rate demonstrates my commitment to excellence and accountability at the highest level.

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🌎 Process Harmonization

I harmonized and globalized procedures so that every team, across every site, operates with consistency and confidence.

    •    Eliminated global compliance issues

    •    Standardized operations worldwide

    •    Created a culture of quality across the board

This effort drove synergy and reliability throughout the organization.

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🤝 Process Development

To strengthen supplier performance, I designed a robust Supplier Management Process that:

    •    Identifies and mitigates risks early

    •    Continuously monitors supplier quality

    •    Builds strong, long-term partnerships

This system ensures supplier excellence and product reliability every step of the way.

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⚡️ Inspection Backlog Reduction

Backlogs can cripple production. I refused to let that happen by:

    •    Creating powerful quality metrics and tools

    •    Building and leading a cross-functional team

    •    Eliminating inspection delays that once caused shutdowns and missed deliveries

The result? A leaner, faster, and more reliable production flow.

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📋 Inspection Plan Backlog

When faced with a massive system migration, I stepped up and:

    •    Reviewed and activated over 807 inspection plans in a single quarter

    •    Supported an on-time and flawless migration

    •    Protected quality throughout a critical system change

This achievement kept operations running seamlessly during a potentially disruptive transition.

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🔥 My Passion for Quality Excellence

Every achievement listed above is fueled by one thing: an unwavering dedication to operational excellence. I don’t just improve systems – I build foundations for success that last.

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Are You Ready to Elevate Your Quality Systems?

Let’s connect! I bring passion, strategy, and proven results to every organization I work with.

👉 Visit https://www.JeramieRegis.com to learn how I can help you achieve breakthrough results.