Medical Device Consultants Near Me in Massachusetts
Jeramie Regis Sr is a Quality and Compliance professional with 14+ 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.
Searching for an experienced medical device consultant near you in Massachusetts?
Jeramie Regis Sr provides hands-on medical device Quality Engineering, Supplier Quality, Quality Assurance, compliance, remediation, validation, investigation, and manufacturing quality support for organizations operating within regulated environments.
With 14+ years of medical device quality experience, Jeramie brings practical experience supporting quality systems, suppliers, manufacturing operations, inspections, investigations, corrective actions, post-market activities, and continuous improvement initiatives.
Serving Boston, Greater Boston, Greater Massachusetts, and surrounding areas, with remote consulting opportunities available depending on project requirements.
Need Medical Device Quality Support?
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Medical Device Consulting Services
Organizations may need additional quality expertise during periods of growth, remediation, supplier issues, audits, manufacturing challenges, validation activities, or temporary resource constraints.
Jeramie provides project-based and consulting support in areas including:
Quality Engineering
• Nonconformance and NCR support
• MRB investigations and coordination
• Root cause analysis
• Corrective action support
• Manufacturing quality
• Quality documentation review
• Process improvement
• Continuous improvement
• Product and process investigations
• Backlog reduction
Supplier Quality Engineering
• Supplier qualification support
• Supplier management
• Supplier performance monitoring
• Supplier issue resolution
• SCAR support and follow-up
• Supplier documentation review
• Component verification
• Incoming quality support
• FAI support
• Risk-based supplier oversight
What component experience does Jeramie Sr have?
Jeramie's experience includes working with mechanical components, electronic components, machined and CNC components, passivated metal parts, and printed circuit board assemblies (PCBAs).
CAPA & Remediation Support
Medical device organizations sometimes require additional resources to resolve aging investigations, corrective actions, audit findings, documentation gaps, or quality backlogs.
What Medical Device experience does Jeramie Regis Sr have?
Yes, Medical Device support may include:
• CAPA activities
• Root cause investigations
• Nonconformance remediation
• Documentation remediation
• Backlog reduction
• Quality record review
• Corrective action follow-up
• Process improvement
• Quality system gap support
Audit Readiness & Compliance Support
Prepare your quality organization and documentation for internal and external reviews.
Does Jeramie Regis Sr support audits?
Yes, support may include:
• Audit readiness
• Evidence gathering
• Documentation review
• Gap assessments
• Remediation activities
• Quality system support
• Internal audit preparation
• Cross-functional audit support
Process Validation & Verification Support
Support is available for medical device manufacturing and quality activities involving:
• IQ/OQ/PQ review
• Process verification
• Component verification
• Inspection requirements
• Validation documentation
• Manufacturing process support
• Risk-based quality review
Does Jeramie Regis Sr have Post-Market experience?
Yes, Post-Market & Complaint Support may include:
• Complaint handling
• Complaint investigations
• Post-market surveillance
• Adverse event review support
• Trending and data analysis
• Quality record review
• Escalation support
• Remediation and backlog reduction
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Does Jeramie Regis Sr have experience in FDA-Regulated & ISO-Driven Environments?
Yes, Jeramie Regis Sr has experience working within regulated medical device environments and quality systems aligned with requirements and standards including:
• FDA medical device quality requirements
• 21 CFR Part 820
• ISO 13485
• ISO 9001
• ISO 14001
• MDSAP
• Quality Management Systems
• Supplier Quality Management
• CAPA and nonconformance systems
The focus is practical execution: identifying problems, strengthening documentation, supporting investigations, reducing quality risk, and helping organizations maintain effective and sustainable quality processes.
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Why Work With Jeramie Regis Sr?
14+ Years of Medical Device Quality Experience
Jeramie’s background spans multiple areas of the medical device product lifecycle, including Quality Assurance, Quality Engineering, Supplier Quality, Supplier Management, Quality Inspection, Manufacturing Quality, Post-Market Surveillance, Complaint Handling, CAPA, remediation and continuous improvement.
Hands-On Quality Experience
Consulting support is based on practical experience working within regulated manufacturing and quality environments—not simply theoretical knowledge.
Cross-Functional Experience
Quality problems rarely exist within one department.
Jeramie has experience collaborating with Quality, Engineering, Manufacturing, Operations, suppliers, project teams and other stakeholders to resolve problems while maintaining business and compliance objectives.
Where is Jeramie Regis Sr located?
Jeramie Regis Sr is a Massachusetts-Based Support
Organizations searching for a medical device quality consultant near Boston or elsewhere in Massachusetts can receive local support depending on project location and requirements.
Remote opportunities may also be considered.
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Are you looking for a Medical Device Consultant Serving Massachusetts?
Jeramie Regis Sr provides medical device quality consulting and professional support throughout Boston and Greater Massachusetts, including organizations in and around:
Boston • Cambridge • Waltham • Burlington • Bedford • Billerica • Marlborough • Framingham • Newton • Dedham • Norwood • Canton • Stoughton • Quincy • Braintree • Weymouth • Somerville • Medford • Beverly • Danvers • Peabody • Acton • Raynham • Bridgewater • Natick
Frequently Asked Questions
Where can I find a medical device consultant near me in Massachusetts?
Jeramie Regis Sr provides medical device Quality Engineering and Supplier Quality consulting support across Boston and Greater Massachusetts. Services include Quality Engineering, Supplier Quality, CAPA, remediation, audit readiness, investigations, validation support, manufacturing quality and quality system improvement.
What does a medical device quality consultant do?
A medical device quality consultant can provide specialized support for quality systems, investigations, CAPA, supplier quality, manufacturing quality, audits, validation, remediation and other activities within regulated medical device environments.
Does Jeramie Regis Sr provide Supplier Quality consulting?
Yes. Jeramie’s experience includes Supplier Quality Engineering, supplier qualification, supplier management, supplier performance, SCAR activities, component verification, supplier issue resolution and risk-based supplier oversight.
Can Jeramie help with CAPA and remediation projects?
Yes. Experience includes CAPA, investigations, remediation activities, backlog reduction, nonconforming material, root cause analysis, corrective actions and quality system improvements.
Does Jeramie support medical device audits?
Yes. Support may include audit preparation, documentation review, evidence gathering, gap assessments, remediation activities and cross-functional audit support.
Does Jeramie provide process validation support?
Yes. Jeramie’s experience includes process validation and verification activities such as IQ, OQ and PQ support, component verification, inspection requirements and validation documentation.
What areas does Jeramie Regis Sr serve?
Jeramie is based in Massachusetts and supports opportunities throughout Boston, Greater Boston and Greater Massachusetts. Remote or out-of-state projects may also be considered depending on scope and project requirements.
How much does medical device consulting cost?
Consulting costs depend on the project’s scope, complexity, timeline, location, required deliverables and level of support. Contact Jeramie Regis Sr with detailed project requirements to discuss availability and pricing.
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Looking for a Medical Device Consultant Near You?
Whether your organization needs temporary Quality Engineering support, Supplier Quality expertise, CAPA assistance, remediation, audit readiness, validation support, manufacturing quality assistance or additional resources for an important quality project, let’s discuss your needs.
