Jeramie Regis Sr. | Design Quality Engineer Supporting Medical Device Development, Design Controls, Risk Management, and Regulatory Compliance
- jeramieregis
- 3 hours ago
- 3 min read
Building Quality Into Medical Devices From Concept to Commercialization
The most effective medical device quality systems do not wait until production to identify quality issues.
Quality starts during design and development.
Every design decision, risk assessment, verification activity, validation effort, and design review contributes to product safety, regulatory compliance, and patient outcomes.
As a Medical Device Quality Professional, I understand the importance of integrating quality throughout the product lifecycle to help organizations develop safe, effective, and compliant medical devices.
My commitment is simple:
Design with quality. Develop with confidence. Protect patients.
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What Is a Design Quality Engineer?
A Design Quality Engineer (DQE) helps ensure quality is incorporated throughout the design and development process.
Design Quality Engineers work closely with Engineering, Regulatory Affairs, Manufacturing, Supplier Quality, Program Management, and Operations teams to ensure products meet:
User Needs
Design Inputs
Design Outputs
Risk Management Requirements
Regulatory Requirements
Product Performance Expectations
Patient Safety Requirements
The goal is to identify risks early and prevent costly issues later in development.
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Design Quality Support Areas
Design Controls
Strong design controls create the foundation for regulatory compliance and product quality.
Support includes:
Design Planning
Design Reviews
Design Inputs
Design Outputs
Design Verification
Design Validation
Design Transfer
Design History File (DHF) Support
Traceability Activities
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Risk Management
Risk management plays a critical role throughout the design lifecycle.
Support includes:
Risk Identification
Risk Analysis
Risk Evaluations
Hazard Assessments
Risk Mitigation Reviews
Residual Risk Evaluations
Risk Documentation Reviews
Patient safety must remain at the center of every design decision.
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Verification and Validation
Verification and Validation activities help confirm products perform as intended.
Support includes:
Design Verification
Ensuring the design meets specifications.
Design Validation
Ensuring the product meets user needs and intended use.
Support may include:
Protocol Reviews
Test Documentation Reviews
Traceability Reviews
Requirements Verification
Validation Planning
Data Review Activities
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Product Development Support
Cross-functional collaboration is critical throughout product development.
I have experience supporting teams involved in:
Product Development
Quality Engineering
Manufacturing Engineering
Supplier Quality
Regulatory Affairs
Operations
Program Management
This collaboration helps identify risks early and accelerate successful product launches.
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Supplier Quality Integration
Design quality extends beyond internal processes.
Supplier quality can significantly impact product performance and compliance.
Support areas include:
Supplier Qualification
Supplier Risk Assessments
Supplier Change Evaluations
Component Quality Reviews
Supplier Corrective Actions
Supplier Performance Monitoring
Strong supplier controls help reduce design and manufacturing risks.
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Medical Device Standards and Regulatory Experience
Experience supporting quality systems aligned with:
FDA Regulations
FDA 21 CFR Part 820
Quality System Regulation (QSR)
International Standards
ISO 13485
Risk-Based Quality Principles
Core Quality Processes
Design Controls
Risk Management
CAPA
Supplier Controls
Change Control
Validation Activities
Complaint Handling
Post-Market Surveillance
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Why Design Quality Matters
Strong Design Quality Engineering helps organizations:
✅ Reduce Product Development Risk
✅ Improve Product Reliability
✅ Strengthen Regulatory Compliance
✅ Improve Audit Readiness
✅ Support Faster Product Launches
✅ Reduce Design-Related Issues
✅ Improve Traceability
✅ Enhance Product Performance
✅ Protect Patient Safety
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Cross-Functional Leadership
Successful Design Quality Engineers connect multiple departments.
I work effectively across:
Quality
Engineering
Manufacturing
Regulatory Affairs
Operations
Supply Chain
Suppliers
Executive Leadership
The strongest medical device companies build quality through collaboration.
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Why Companies Choose Jeramie Regis Sr.
Organizations need professionals who can:
✔ Understand Design Controls
✔ Support Product Development
✔ Facilitate Risk Management Activities
✔ Strengthen Verification and Validation Processes
✔ Improve Supplier Quality Integration
✔ Support Regulatory Compliance
✔ Improve Cross-Functional Collaboration
✔ Protect Patient Safety
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Looking for Design Quality Engineering Support?
Whether your organization is developing new medical devices, improving existing products, strengthening design controls, managing risk, supporting verification and validation activities, or preparing for audits, I am available to help support your quality objectives.
Jeramie Regis Sr.
Medical Device Quality Professional
Boston & Greater Massachusetts | Remote Support Available
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