Jeramie Regis Sr. – Experienced Medical Device Quality Professional Supporting Supplier Quality, Product Quality, Compliance, and Patient Safety

Trust. Transparency. Reliability. Results.

In the medical device industry, quality is more than a requirement—it is a responsibility. Every supplier qualification, risk assessment, complaint investigation, process validation, audit response, and product review ultimately impacts patient safety.

That is why organizations need professionals who understand the entire quality ecosystem, from supplier onboarding to post-market surveillance.

My name is Jeramie Regis Sr., and I have spent years supporting medical device manufacturers, suppliers, and cross-functional teams by helping organizations strengthen quality systems, improve compliance, reduce risk, and maintain regulatory readiness.

Extensive Medical Device Quality Experience

Throughout my career, I have supported multiple areas of the medical device lifecycle, including:

Supplier Quality Engineering

Supplier Qualification and Management

Supplier Audits

Manufacturing Quality

Product Quality Assurance

Quality Engineering

Quality Inspection

Quality Control

Process Validation

CAPA Management

Root Cause Investigations

Nonconformance Management

Complaint Handling

Post-Market Surveillance

Risk Management

Regulatory Compliance

Audit Readiness

Continuous Improvement

Data Trending and Analysis

Cross-Functional Collaboration

I bring a practical, risk-based approach that helps organizations achieve compliance while maintaining operational efficiency.

Supplier Quality Expertise

Strong suppliers create strong products.

I have experience supporting supplier quality programs from onboarding through continuous improvement, including:

Supplier Qualification

Supplier assessments

Supplier onboarding

Risk evaluations

Supplier performance monitoring

Supplier quality agreements

Supplier Management

Supplier corrective actions

Quality issue resolution

Supplier performance metrics

Escalation management

Continuous improvement initiatives

Supplier Audits

Audit preparation

Audit participation

Gap assessments

CAPA development

Compliance remediation

My focus is ensuring suppliers consistently meet quality expectations while supporting business objectives.

Product Quality and Manufacturing Support

Medical device quality requires collaboration across multiple departments.

I have supported:

Product release activities

Manufacturing investigations

Device history record reviews

Product nonconformance investigations

Material review board activities

Risk assessments

Process monitoring

Product performance trending

Manufacturing quality improvements

My experience helps bridge communication between Quality, Manufacturing, Engineering, Regulatory Affairs, Operations, and Suppliers.

Medical Device Regulatory and Standard Experience

I have experience working within quality systems and regulatory environments aligned with:

FDA Regulations

FDA 21 CFR Part 820

Quality System Regulation (QSR)

Quality Management System requirements

International Standards

ISO 13485

Risk-based quality principles

Supplier controls

Design and manufacturing controls

Documentation and record requirements

Quality System Processes

CAPA

Complaint Handling

Change Control

Risk Management

Validation Activities

Internal Audits

Supplier Controls

Post-Market Activities

Medical Device Class Experience

I have supported quality activities involving various medical device classifications and technologies, including regulated products requiring strict quality oversight, supplier controls, documentation management, risk evaluation, and compliance support.

Experience includes supporting organizations operating within highly regulated environments where patient safety, product performance, and regulatory compliance are critical.

Cross-Functional Leadership

One of the greatest strengths I bring to organizations is my ability to work across departments.

I understand how Quality impacts:

Engineering

Manufacturing

Operations

Regulatory Affairs

Supply Chain

Purchasing

Suppliers

Executive Leadership

This allows me to help teams solve problems faster, improve communication, and implement sustainable solutions.

Why Organizations Work With Jeramie Regis

Organizations need professionals who can do more than identify problems.

They need professionals who can:

✓ Build trust with suppliers

✓ Support quality systems

✓ Reduce compliance risk

✓ Strengthen audit readiness

✓ Improve operational efficiency

✓ Drive corrective actions

✓ Protect patient safety

✓ Support business growth

My Commitment

I believe quality should be proactive, not reactive.

I am committed to helping organizations:

Improve supplier performance

Strengthen quality systems

Reduce risk

Maintain compliance

Support product quality

Protect patients

Because every quality decision matters.

Looking for Medical Device Quality Support?

Whether your organization needs assistance with supplier quality, quality engineering, manufacturing quality, CAPA remediation, audit readiness, post-market surveillance, or quality system improvements, I am ready to help.

Trust. Transparency. Reliability. Excellence.

When patient safety matters, quality matters.

When quality matters, experience matters.

Serving Boston & Greater Massachusetts | Remote Support Available

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