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
✔ 10+ Years of Proven Experience in FDA-Regulated & ISO-Certified Environments
✔ Trusted Across Supplier Quality, CAPA, MRB, Audits, and Product Release
✔ Supporting Massachusetts & Greater Massachusetts Organizations
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.
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.
