SAP
Nicholas Colombo
Quality Assurance Associate
Maple,Ontario
Summary
Dedicated Quality Assurance Professional in the medical device and
pharmaceutical industry with 5 years experience in complaints and
adverse event reporting. Dedicated to ensuring product quality and compliance, and I am motivated by the opportunity to contribute to the health and safety of the public.
Overview
6
6
years of professional experience
2
2
Certifications
Work History
Quality Assurance Associate
Medline Canada
09.2020 - Current
- Manage approximately 1,000 quality complaints annually for medical devices, pharmaceuticals, cosmetics, textiles, and natural health products across Canada, ensuring compliance with ISO 13485 and internal SOPs.
- Log and triage complaints using SAP, coordinate investigations with vendors, issue stock checks, Certificates of Destruction (COD), handle returns/replacements, and escalate critical issues to QA Manager as needed.
- Track complaint lifecycle using a custom Smartsheet tool; assess reportability, initiate regulatory investigations, and draft adverse reaction reports for submission to Health Canada.
- Support national brand recalls, contribute to CAPA investigations, complete action items, and ensure effectiveness checks are met.
- Collaborate with QC Inspectors on sample handling, develop DMRs (e.g., Alliance facemask with faceshield)
- Participated in Health & Safety and Employee Appreciation Week initiatives.
Quality Assurance and Regulatory Affairs Associate
Seaford Pharmaceuticals Inc.
02.2020 - 09.2020
- Supported batch inspection and product release in compliance with SOPs
- Assisted with deviations & complaints
- Helped review stability data
- Performed document control tasks (filing, archiving, retention)
- Contributed to the renewal of their Natural Health Product (NHP) Site Licence
Junior Quality Compliance Associate
Regulatory Solutions Inc. / Generic Medical Partners Inc. (Client Office)
08.2019 - 11.2019
- Initiated and completed electronic/non-electronic Quality Dossiers to support product release
- Managed Change Controls following a Post-Notice of Compliance (Post-NOC)
- Handled Deviation Reports, primarily related to temperature excursions
- Assisted with stability tracking and data updates
- Organized documentation to ensure easy access within online Quality Dossiers
- Supported Annual Product Quality Review (APQR) compliance checks
Education
Bachelor of Science - Chemistry
York University
05.2001 -
Post-Graduate Certificate - Regulatory Affairs
Humber College
05.2001 -
Skills
Complaints
Strong follow-up skills
Adverse Event Reporting
Use of Computers / Programs
Microsoft Office
SAP
Device Master Records (DMRs)
Time Management
Organization
Certification
Medical Device Establishment Licensing and Post-Market Regulation | Public Health Agency of Canada
Software
Timeline
Medical Device Establishment Licensing and Post-Market Regulation | Public Health Agency of Canada
02-2024
Quality Assurance Associate
Medline Canada
09.2020 - Current
Pharmaceutical Quality Assurance & Regulatory Affairs | Technology Ed
07-2020
Quality Assurance and Regulatory Affairs Associate
Seaford Pharmaceuticals Inc.
02.2020 - 09.2020
Junior Quality Compliance Associate
Regulatory Solutions Inc. / Generic Medical Partners Inc. (Client Office)
08.2019 - 11.2019
Bachelor of Science - Chemistry
York University
05.2001 -
Post-Graduate Certificate - Regulatory Affairs
Humber College
05.2001 -