Quality Control professional with 20 years experience in the Manufacturing Medical Device Industry. Proficient in reviewing, reporting and inspecting product and documentation to ensure requirements are met before release. Highly-motivated employee with the ability to work independently and collaborate in a team setting. Skilled in working under pressure and adapting to new situations. Organized and tackles obstacles head-on, demonstrating resilience and determination. Active listener, patient and empathetic when communicating with colleagues. Passionate about personal growth while achieving company goals.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Quality Inspector IV
Boston Scientific (Acquired Baylis Medical Company)
Mississauga
08.2004 - Current
Review Sterility, LAL, Bioburden, Process Control documents to ensure requirements are met for product release.
Reviewed manufacturing and Environmental documents for accuracy and completeness.
Conducted internal audits to verify compliance with ISO standards. Also supported the audit team for successfully completing FDA and SGS Audits.
Collaborated with cross-functional teams on process improvements.
Coordinated a project to create a SharePoint Portal to request records, which reduced the turn around time from one week to one day.
Cataloged, organized, and preserved historical documents and materials.
Collaborated with outside vendors on digitization projects involving archives, Unify Active File Management System.
Supported integration projects in Supply Chain to migrate distribution operations.
Provided coaching and feedback on employee performance, encouraging professional development.
Inspected products for quality, ensuring adherence to specifications.
Collaborated with production team to address quality issues.
Matched arriving materials with purchase orders, submitted discrepancy forms as necessary.
Trained new employees on inspection processes and guidelines.
Documented, filed and maintained proper inspection records and quality assurance documents.
Conducted dimensional checks with various measuring instruments including micrometers, calipers and gauges.
Education
Some College (No Degree) - Electronics And Telecommunications
DeVry Institute of Technology
Mississauga, ON
06-2002
Skills
Reporting and documentation
ERP, MES, SAP and eRelease
Microsoft Office (Word, PowerPoint, Excel)
Sharepoint
Strong organizational and attention to detail
Strong verbal and written communication
Critical thinking and problem solving
Able to adapt to change and prioritize responsibilities to meet deadlines
Certification
Data Integrity Certificate of Completion Mar-2024
Lean Essentials Certificate of Completion April-2024
References
References available upon request.
Timeline
Quality Inspector IV
Boston Scientific (Acquired Baylis Medical Company)
08.2004 - Current
Some College (No Degree) - Electronics And Telecommunications
DeVry Institute of Technology
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