Top Quality Engineer & Supplier Quality Engineer in Massachusetts
Driving Supplier Quality, Compliance, Inspections, and Data-Driven Excellence in Medical Device Manufacturing
Services that Jeramie provide
Jeramie Regis is a trusted Medical Device Quality Professional with hands-on experience across audit readiness, CAPA systems, supplier quality, and regulatory compliance—supporting organizations in achieving consistent, inspection-ready operations aligned with global standards.
✔ 10+ Years of Proven Experience in FDA-Regulated & ISO-Certified Environments
✔ Proven experience across multiple quality functions
✔ Trusted Across Supplier Quality, CAPA, MRB, Audits, and Product Release
✔ Supporting Massachusetts & Greater Massachusetts Organizations
✔ Trusted to identify high-risk audit gaps before regulators do
✔ Known for turning recurring findings into permanent solutions
✔ Committed to patient safety, compliance, and operational excellence
Jeramie Regis Sr is a results-driven Quality Engineer and Supplier Quality Engineer with over a decade of hands-on experience supporting medical device manufacturing, supplier quality systems, inspections, audits, and compliance-driven operations.
Known for transforming documentation systems into audit-ready frameworks that meet FDA expectations with clarity, consistency, and traceability.
Recognized for building supplier quality systems that reduce risk, improve consistency, and withstand regulatory scrutiny.
From supplier qualification and component verification to post-market surveillance and audit readiness, Jeramie brings a full lifecycle quality mindset that helps organizations reduce risk, improve product quality, and maintain compliance.
📍 Serving: Massachusetts, Greater Massachusetts, and surrounding regions
🌐 JeramieRegis.com
Supplier Quality Engineering
• Supplier Qualification (FAI, SPQ, TVR)
• Supplier Monitoring & Performance Support
• Supplier Audits & Documentation Review
• SCAR & Corrective Action Follow-Up
• Metals, CNC, Passivation, and PCBA Verification
Quality Engineering
• Product & Process Escalation Support
• Product Release Review & Approvals
• Document Review & Compliance
• Process Development & Harmonization
• Backlog Reduction & Workflow Optimization
Quality Inspection & Verification
• Incoming Inspection
• Component Verification
• Gage R&R Support
• Inspection Planning & Execution
• MRB Coordination & Material Flow
Post-Market Surveillance
• Complaint Handling
• MDR / ADE Review Support
• Field Alert Reporting (FAR)
• Investigation Ownership
• Data Trending & Risk Identification
Audit & Compliance Support
• FDA & ISO Environment Support
• ISO 13485 / 9001 / 14001
• Internal & External Audit Support
• Documentation Readiness
• Cross-Functional Audit Coordination
Why choose Jeramie Regis Sr
✔ End-to-End Quality Expertise (Supplier → Production → Post-Market)
✔ Strong Cross-Functional Leadership
✔ Data-Driven Decision Making (Power BI, Tableau)
✔ Proven Ability to Reduce Risk & Improve Efficiency
✔ Consistent Performance in High-Pressure Environments
Experience
• Supplier Quality Engineer
• Quality Engineer
• Quality Inspection Engineer
• Post-Market Surveillance Specialist
• MRB / Non-Conforming Material Management
Supporting companies including:
• Medical Device Manufacturing Organizations
• Supplier-Driven Environments
• FDA-Regulated & ISO-Certified Systems
Tools & Systems
Platforms:
SAP, Salesforce, JIRA, LIMS, MasterControl, ETQ, Arena, Windchill
Analytics:
Power BI, Tableau
Core Quality Tools:
CAPA, SCAR, SPQ, FAI, Gage R&R, ECO, DCO, MRB
Ideal Opportunities
• Supplier Quality Engineer Roles
• Quality Engineer Roles
• Quality Assurance
• Manufacturing Quality
• Medical Device Quality Positions
• BioTech Quality Positions
• Supplier Development & Oversight
Contract / Consulting / Full-Time Roles
Ready to Strengthen Your Quality Systems?
If your organization needs a proven Quality Engineer or Supplier Quality Engineer with real-world experience in supplier quality, inspections, audits, and compliance, let’s connect.
FAQ
Q: What does a Supplier Quality Engineer do?
A: A Supplier Quality Engineer ensures suppliers meet quality standards through audits, qualifications, inspections, and corrective actions to reduce risk and improve product quality.
Q: What industries does this experience support?
A: Primarily medical device and regulated manufacturing environments requiring FDA and ISO compliance.
Q: What makes Jeramie Regis Sr different?
A: A full lifecycle quality background—from inspection and supplier quality to post-market surveillance and audit readiness.
Q: Is Jeramie available for consulting?
A: Yes, available for contract, consulting, and full-time opportunities.
