Tammy Robinson
Sr. Client Manager / Lead QA Auditor - Healthcare - Medical Devices at BSI
- Role
- Senior Client Manager Lead Qa Auditor - Healthcare - Medical Devices at BSI
- Location
- Fort Myers, FL, US
- LinkedIn followers
- 500 followers
About Tammy Robinson
Career professional of over 30 years (15 years in medical device and additional 15 years in engineering). Medical device experience (industry and auditing) includes active non-implantable, active implantable, non-active implantable, medical devices incorporating medicinal substances, medical devices utilizing tissues of animal and human derives, reusable surgical instruments, devices controlled by software, devices with measurement functions, devices for wound care, non-active dental devices, devices for radiation therapy, and IVD medical devices. Possess extensive knowledge and experience in Quality Management Systems including product technical documents with regulatory requirements of ISO 13485, FDA 21 CFR 820, EU regulations MDD 93/42/EEC, AIMD 90/385/EEC, MDR 2017/745, UK (Part II of Medical Devices Regulations 2002), MDSAP (USA (21 CFR 820, 803, 806, 807, 821), Australia (Therapeutic Goods MD Regulation 2002), Canada (SOR 98/282), Japan (MHLW 169), Brazil (RDC ANVISA n.
Experience
Senior Client Manager Lead Qa Auditor - Healthcare - Medical Devices
May 2020 — Present · FL, US
Delivered Notified Body external audit services to clients (domestically and international) in accordance with regulatory requirements while assuring timely, cost-effective service delivery to customer satisfaction and needs. Analyze quality systems and provide recommendations of certifications of ISO 13485, ISO 9001, MDD, MDR, UK, and MDSAP of medical devices. Manage client\'s portfolio including contact, scheduling visits, planning assessments, conducting assessments, and report writing. Lead teams when necessary and mentor inexperienced colleagues as needed. Mentor assessors including but not limited to training, service capability, observing, qualifying, and report reviewing.
Education
University of North Dakota
Bachelor of Science - BS, Civil Engineering
WNU
Bachelor of Science - BS, Environmental Engineering
Front Range Community College
Biology
Colorado School of Mines
Hydrology
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.