Medical Device Quality & Compliance Services in Massachusetts
Jeramie Regis Sr is a Quality and Compliance professional with 12+ years of hands Quality Assurance, Quality Engineer, Supplier Quality Engineer, Supplier Management, Supplier Qualification, Manufacturing Quality, Quality Inspections and Verification, IQ/OQ/PQ, Quality Control, Post Market Surveillance, Complaint Handling, Remediation, Backlog Reduction, MRB Coordinator, SCAR, CAPA, Investigations,
Non-Conforming Material, Continuous Improvement, and Process Improvement.
Supporting FDA-regulated and ISO-driven organizations in Boston and the Greater Massachusetts area.
Services that Jeramie provide
Jeramie Regis provides Medical Device Quality and Supplier Quality support for organizations operating in regulated medical device environments, bringing hands-on experience across Quality Engineering, audits, CAPA, complaint handling, post-market surveillance, and remediation.
This service is designed for companies that need execution—not theory. Whether supporting daily quality operations, preparing for inspections, addressing supplier issues, or strengthening documentation, Jeramie works directly within established quality systems to help teams close gaps, reduce risk, and maintain compliance. Experience-based knowledge rooted in real manufacturing, validation, and compliance environments within the medical device industry.
Experience includes working within frameworks aligned to:
• ISO 13485
• ISO 9001
• ISO 14001
• ISO 2859-1
• MDSAP
• TUV
• 21 CFR Part 820
• Regulated manufacturing and supplier environments
Services support manufacturers, suppliers, and cross-functional teams navigating quality challenges while maintaining operational momentum. The approach is structured, risk-based, and documentation-driven, ensuring outputs are inspection-ready and defensible.
Serving organizations across Boston, Greater Massachusetts and beyond, this support is ideal for teams that need:
• Temporary or project-based quality expertise
• Supplier issue resolution and escalation support
• Audit readiness and remediation deliverables
• Strong communication between quality, operations, and suppliers
Over 9 Years of Experience
✔️ Regulated Industry Experience
✔️ Documentation & Audit Support
✔️ Quality Systems Knowledge
✔️ Quality Assurance
✔️ Quality Engineering
✔️ Supplier Quality
✔️ Manufacturing Quality
✔️ Quality Inspections
✔️ Post Market Surveillance
✔️ Remediation
✔️ Backlog Reduction
Insulet, Corp
Achievement: Performed gap assessment for electronic and metals commodities while contributing in improving Supplier Product Management.
Abiomed (J&J MedTech)
Achievement: Coordinated product through incoming inspection to meet on time deliveries, prevent production shutdowns, and successfully reduce inspection backlog.
Also collaborated in process improvement and cross functional projects.
Johnson & Johnson
Achievement: Successfully spearheaded a project to improve and reduce the waste in incoming inspection through incoming assessments, process improvement globally through standardization and harmonization.
Quanterix Corp
Achievement: Successfully created, implemented and owned a supplier management process that consisted of Supplier Qualifications, Supplier Audits, Supplier Profiles, and Supplier Continuous Improvement projects.
Optos, Inc
Achievement: Successfully created and owned non-conforming processes that reduced material in MRB (Material Review Board) from 1 Million to under 34k. All improved product traceability internally and externally while improving close looped investigation.
Fresenius Medical Care North America
Achievement: Successfully trained audit backroom support to improve the response time in audit requests. Assisted in projects to successfully close out warning letter(s). Contributed to achieving on time review of complaints and MDR reporting.
Zyno Medical
Achievement: Owned and Improved the product management of new and existing product. Supported in coordinating the launch of new product through production, existing product through normal periodic maintenance and upgrades as well as leases for existing customers.
A few Achievements
by Jeramie Regis
CORE MEDICAL DEVICE SERVICES
Quality Engineering Support
• NCR & MRB investigation support
• Root cause analysis & corrective actions
• Process improvement initiatives
• Cross-functional quality collaboration
Supplier Quality
• SCAR creation & follow-up
• Supplier issue resolution
• Risk-based supplier oversight
• Metal Component Inspection & Verification
(CNC, Machined, Passivated Parts)
• PCBA Component Inspection & Verification
(CNC, Machined, Passivated Parts)
• Component Qualification, Verification, and Validation
(IQ/OQ/PQ Support)
• Mechanical Components
• Electronic Components
• Metal (Machined, Passivated, CNC)
• Printed Circuit Board Assembly (PCBA)
• Quality Review & Data Trending
Audit & Compliance Support
• Internal audit readiness
• External audit preparation
• Evidence gathering & gap assessment
• Remediation planning and execution
Post-Market & Complaint Handling
• Complaint intake & investigation support
• Trending and data analysis
• Post-market surveillance activities
If you’re searching for medical device quality or supplier quality support in the Massachusetts area, Jeramie Regis provides hands-on Quality Engineering, audit readiness, CAPA, and supplier issue resolution services within regulated environments.
Serving Boston, Greater Boston, Beverly, Acton, Cambridge, Bridgewater, Raynham, Waltham, Billerica, Quincy, Medford, Malden, Peabody, Danvers, Braintree, Weymouth, Newton, Somerville, and surrounding Massachusetts communities.
What medical device services does Jeramie Regis offer?
Quality Engineering, Supplier Quality Engineer, Supplier Management, Manufacturing Quality, Quality Inspections, Complaint Handling, Post Market Surveillance, Quality Control, Remediation, Backlog Reduction, MRB Coordinator, SCAR, CAPA, Investigations, Non-Conforming Material, Continuous Improvement, Process Improvement and more.
How much does Jeramie Regis charge?
My cost is driven by project scope, timeline, location site, and project expectations.
Are services limited to Massachusetts?
Open for discussion but rate may fall outside of budget.
What can I expect?
Good communication, High quality independent work, data on deliverables, teamwork, positive and motivated attitude and full commitment to project.
Do you support audits?
Yes. Support includes preparation, evidence gathering, and remediation activities.
What is the best way to reach me?
Email is the best way to reach me. Please be very transparent and detailed in your email to reduce my delay in responding.
Serving Boston Massachusetts and the Greater Massachusetts areas.
Jeramie Regis provides mobile creative services, professional consulting, digital branding, photography, website development, and performance-based entertainment throughout Massachusetts.