Quality Assurance Specialist
Current
Nov 2024 - Present
AeroLeads people directory · profile
Deb Simpson Email & Phone Number
Quality Assurance Specialist
at
Axena Health
1 work email found
@carestreamdental.com
LinkedIn matched
✓ Verified July 2026
4 data sources
Profile completeness 100%
Current company
Role
Quality Assurance Specialist
Location
Chattanooga, Tennessee, United States
Who is Deb Simpson? Overview
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Quick answer
Deb Simpson is listed as Quality Assurance Specialist at Axena Health, based in Chattanooga, Tennessee, United States. AeroLeads shows a work email signal at carestreamdental.com and a matched LinkedIn profile for Deb Simpson.
Deb Simpson previously worked as Industry Consultant at Sqa Services, Inc. and Principal at Simpson Services Llc. Deb Simpson holds Bachelor Of Science, Management from National-Louis University Gpa 4.0.
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Email format at Axena Health
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{first}.{last}@carestreamdental.com
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Profile bio
About Deb Simpson
Senior Quality Management Professional . QMS Auditor with current certification (TPECS) . Versatile QMS and Management Consultant with 30+ years experience in regulated industry. Experienced with MDSAP and EU MDR requirements and application. Experienced with training development and delivery. Experienced QMS auditor. Hands-on management and leadership of multi-site operations. Developed, implemented and led practices and procedures for start-up operations and various small businesses. Experienced in all phases of operation from preclinical/clinical to full scale commercial manufacturing. Adept in all aspects of leadership, including strategic planning, implementation, and daily management. Led multiple companies in achieving and maintaining Quality Systems certifications and regulatory compliance.
Listed skills include Quality Assurance, Quality System, Fda, Capa, and 45 others.
Current workplace
Deb Simpson's current company
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13 roles · 34 years
Deb Simpson work experience
A career timeline built from the work history available for this profile.
Industry Consultant
Principal
Simpson Services Llc
Qualified Lead Auditor. (ISO 9001/ 13485) . Industry consultant, working independently and with consulting agencies including FDAGroup and FDAQRC. Let me bring my experience and skill to enhance your compliance and strengthen your bottom line. Regulatory Intelligence. CAPA. Supplier Management. Complaint Handling. Non conformance/MRB. Internal and external auditing. Pre-approval inspection readiness. Regulatory remediation leadership. Medical device. Biological. HCTP. Pharmaceutical. Combination products.
Industry Consultant
Industry Consultant, providing Quality Systems expertise for regulated industry, including QMS development and streamlining; Quality System Audits for compliance, improvement, pre-approval inspection (PAI) prep, certification prep, supplier oversight, process improvement, and CAPA effectiveness verification. Experienced with Medical Device, Biologic, Pharmaceutical, Tissue based products, and combination products -FDA Class 1,2,& 3. (510k & PMA).
Affiliate Consultant, Quality And Regulatory Affairs
Oriel STAT A MATRIX provides life sciences organizations with consulting, training, and audit support to achieve compliance with US FDA and global regulations like EU MDR and EU IVDR. Regulatory Submissions. Regulatory Intelligence.
Head Of Quality, Director Quality Systems
Jun 2021 - Apr 2024
Global Quality Systems Manager
Nov 2018 - Jun 2021
Sr. Manager, Quality Systems
Biomimetic Therapeutics
Quality Systems management for Medical Device company, including SOP development and implementation, CAPA programs, Internal Audit Management, Supplier Management and Global Supplier Audits; to meet FDA, Canadian, Australian, European, and other global regulations. Primary product: Class III PMA approved combination (Device/ pharma/ biologic) QMS qualification to 13485/9001/14971
2009 - 2016
~7 yrs
Director Of Qa & Customer Care
Head of quality and regulatory functions. Responsible for all aspects of Quality Systems and staff to meet company and regulatory requirements; Responsible for all aspects of customer care and staff, from new orders-from order to delivery; responsible for primary production schedule planning. Medical electronics--vital signs device software with direct electronic records input; ; software controlled medication access systems.
Aug 2006 - Sep 2008
Quality Manager
Head of quality operations including Product Release. Document Management. QC inspection. CAPA program. Nonconforming product. Animal test lab. Design and development. Responsible for quality assurance supporting human musculoskeletal and cardiac tissue processing operations at both the Alabama and Florida site. Responsible for development of quality system protocols and procedures for ISO Class 4 cleanroom operations, facility start-up and AATB accreditation. Included orthopedic device/ tissue combination products. HCTP
2003 - 2006
~3 yrs
Qara Manager
Responsible for all aspects of quality and regulatory management, from development thru post marketing, for custom-made, customized and catalog tracheotomy devices, voice restoration devices, and veterinary tracheotomy devices. (e.g. CE Marked silicone based products , extruded and molded in house)Management representative and most senior QA/RA person on site.
2001 - 2003
~2 yrs
Quality Manager
Responsible for the implementation and management of Quality and Regulatory of processes, for drug delivery device design and manufacture. Projects included respiratory inhalers, innovative insulin delivery systems, and other Drug/Device combination products. Onsite manufacturing operations included automated polymer Injection molding, automated assembly and validated automatic inspection processes. . Management representative and most senior QA/RA person for the company. multi site responsibility
1999 - 2001
~2 yrs
Qa Manager
1991-1999 Interwoven / Offsite Business Unit, Tampa, FL; Quality Manager for five domestic facilities , manufacturing,/ processing reusable surgical linen and instrument (custom) kits. Onsite sterilization, packaging, and labeling supporting Just in time delivery. 1990-1991 Renal Division, McGaw Park, Il; Customer Support for dialysis patients, including Continuous Ambulatory Peritoneal Dialysis equipment, home hemodialysis machines and prescription dialysis solutions. 1986-1989 Intravenous Drug Delivery Business Unit, Round Lake, IL Technical Specialist for Intravenous frozen drugs (cephalosporin, Penicillin). Responsible for operation of Calibration and Sterilization Validation group supporting eight units in site based industrial compound.
1993 - 1999
~6 yrs
3 education records
Deb Simpson education
Bachelor Of Science, Management
National-Louis University Gpa 4.0
Master Of Arts - Ma, English Language And Literature, General
Southern New Hampshire University
Associates Of Science, Electronics Enineering
Trdent Technial College
FAQ
Frequently asked questions about Deb Simpson
Quick answers generated from the profile data available on this page.
What company does Deb Simpson work for?
Deb Simpson works for Axena Health.
What is Deb Simpson's role at Axena Health?
Deb Simpson is listed as Quality Assurance Specialist at Axena Health.
What is Deb Simpson's email address?
AeroLeads has found 1 work email signal at @carestreamdental.com for Deb Simpson at Axena Health.
Where is Deb Simpson based?
Deb Simpson is based in Chattanooga, Tennessee, United States while working with Axena Health.
What companies has Deb Simpson worked for?
Deb Simpson has worked for Axena Health, Sqa Services, Inc., Simpson Services Llc, The Fda Group, Llc, and Oriel Stat A Matrix.
How can I contact Deb Simpson?
You can use AeroLeads to view verified contact signals for Deb Simpson at Axena Health, including work email, phone, and LinkedIn data when available.
What schools did Deb Simpson attend?
Deb Simpson holds Bachelor Of Science, Management from National-Louis University Gpa 4.0.
What skills is Deb Simpson known for?
Deb Simpson is listed with skills including Quality Assurance, Quality System, Fda, Capa, Iso, Quality Management, Medical Devices, and Program Management.
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