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Sarah Clinton

@sarahclinton

Quality Systems Specialist at Medtronic Canada ULC who modernized the Field Corrective Action process, later adopted globally.

Canada
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At Medtronic Canada ULC, I modernized the Field Corrective Action process by introducing Smartsheet, DocuSign, and QR codes to strengthen documentation control and traceability. The process was later adopted globally, and I received the FY23–FY24 Global Quality Function Excellence Award.

I managed quality activities across 40+ Field Corrective Actions, maintaining a 100% on-time completion KPI. I also owned a CAPA from root cause analysis through change control and supported MDSAP audits and a Health Canada inspection.

At Abbott Medical Canada Co., I investigated and closed 350+ complaints annually and prepared more than 150 Mandatory Device Problem Reports for Health Canada each year. I also developed and deployed company-wide compliance training that increased PER compliance by 50%.

Earlier, at PrimeVigilance Ltd., I assessed reportability and coded adverse events using MedDRA, and drafted and reviewed case narratives. I hold ISO 13485 and ISO 19011 Internal Auditor certifications, along with GMP and GCP certifications.

Experience

Work history, roles, and key accomplishments

Medtronic Canada ULC logoMU

Quality Systems Specialist

Nov 2021 - Jul 2026 (4 years 8 months)

Ensured compliance with Health Canada MDR, EU MDR, and FDA 21 CFR 820 across 40+ Field Corrective Actions, maintaining a 100% on-time completion KPI. Owned CAPAs from root cause analysis through change control and supported audits and inspections.

Education

Degrees, certifications, and relevant coursework

Coursera logoCO

Coursera

Professional Certificate, Project Management

Google Project Management Professional (PMP) certificate from Coursera with Google, currently in progress.

University of Exeter logoUE

University of Exeter

Postgraduate Certificate in Education, Education

Postgraduate Certificate in Education (PGCE) from the University of Exeter.

DC

Dowling College

Bachelor of Arts, Biology

Bachelor of Arts in Biology from Dowling College.

ME

Medtronic

Internal Auditor Certification, Quality Management

Internal Auditor Certification for ISO 13485 and 19011, completed at Medtronic.

US Pharmacopeial Convention logoUC

US Pharmacopeial Convention

Certificate, Pharmaceutical Manufacturing

Foundations of Good Manufacturing Practice (GMP) certificate from the US Pharmacopeial Convention.

Coursera logoCO

Coursera

Specialization Certificate, Clinical Research

Clinical Trials: Good Clinical Practice Specialization certificate from Coursera, offered by Novartis.

MedDRA MSSO logoMM

MedDRA MSSO

Course Certificate, Medical Coding

One-day MedDRA coding course provided by MedDRA MSSO in the UK.

Workera logoWO

Workera

Certificate, Artificial Intelligence

AI Essentials course from Workera.

Tech stack

Software and tools used professionally

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