Nimisha Patel
Quality Systems Auditor @Healthcraft Group
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WORK HISTORY
Quality Systems Auditor @Healthcraft Group
Ottawa, ON, CA
Supporting Lead Auditor in conducting product data audits within ODOO eQMS/ERP platform — reviewing Bills of Materials (BOMs) and Operations records to verify correct drawings and SOPs are linked to current product configurations across the manufacturing lifecycle.• Cross-verifying document revisions across engineering drawings and SOPs — identifying revision discrepancies, outdated links, and documentation gaps against quality system requirements, then coordinating remediation directly with stakeholders.• Updating and maintaining controlled quality documents within the eQMS — correcting version control errors, completing missing SOP entries, and restoring document traceability where gaps are found during BOM audit reviews.
EDUCATION
Veer Narmad South Gujarat University (VNSGU), Surat
Bachelor of Science (BSc), Biotechnology
Hemchandracharya North Gujarat University (HNGU), Patan
Master of Science, Biotechnology
Veer Narmad South Gujarat University (VNSGU), Surat
Post Graduate Diploma, Biotechnology
ABOUT NIMISHA PATEL
Quality Assurance professional with 10+ years of experience across medical device, pharmaceutical, and biotechnology sectors. Proven expertise in ISO 13485, ISO 9001, GMP, CAPA, change control, and lot release with a track record of reducing defects by 20%and driving 30% process efficiency gains in regulated manufacturing environments. My approach emphasizes attention to detail, data-driven decision-making, and collaborative continuous improvement to optimize processes and uphold excellence.I bring 4 years of ISO13485 medical device experience at Siemens Healthineers Ottawa and 1 year of GMP pharmaceutical QA at Canopy Growth, where I administered QMS processes with minimal supervision in a fast-paced CMO environment. Currently pursuing ASQ Certified Quality Auditor (CQA) certification-building on a Lean Six Sigma Green Belt and 10+ years of hands-on regulatory compliance experience.Open to QA Specialist, Senior QA Specialist and QMS Specialist opportunities in Ottawa and remotely across C••••••••@gmail.com |+18•••••••26
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