Jennifer Robb work email
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Jennifer Robb personal email
QA leader with a collaborative approach, promoting quality culture throughout the organization. Experienced in design, development, and contract manufacture of medical devices ranging from class II to class III.
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Director Of QualityMy01 Oct 2024 - PresentCanada -
Senior Manager - QualityAgile Mv Oct 2021 - Oct 2024Montreal, Quebec, Canada- Maintain a flexible and compliant QMS tailored to the organization's evolving needs- Led QA teams through over a dozen registrar and customer audits, frequently resulting in no nonconformities or observations. - Work effectively with R&D Team to maintain and support Design Control process for various sterile, single use medical devices (class II and class III)- Ensure commissioning and conformity of newly constructed ISO Class 7 cleanroom to ISO 14644 -
Manager - Quality At Agile MvAgile Mv Mar 2020 - Oct 2021Montreal, Quebec, Canada- Expanded scope of QMS to include EO sterilization- Lead QA team through the first Microbiological audit at the organization- Lead QA team of engineers, technicians, and inspectors- Ensured products are released as per requirements- Maintained control and qualification of critical suppliers
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Senior Qa SpecialistAgile Mv Jun 2018 - Mar 2020Montreal- Expanded scope of QMS to include Contract Manufacturing- Lead QA Team through initial FDA Establishment Registration as Contract Manufacturer- Lead QA Team through the organization's first FDA inspection with no findings or required action (no form 483)- Oversaw Customer Complaint, Nonconfroming Product, Corrective and Preventive Action, and Internal Audit programs
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Qa SpecialistAgile Mv Dec 2014 - Jun 2018Montreal, Canada Area- Maintain compliance of Quality Management System (QMS) to ISO 13485 and 21 CFR part 820 as assessed through registrar, customer, and regulator audits or inspections- Work effectively with R&D Team to maintain and support Design Control process from Concept Phase to Design Transfer- Collect, analyze, and present data on the suitability, adequacy, and effectiveness of the QMS- Create, review, update, and implement Standard Operating Procedures (SOPs) (e.g. Production, Order Processing, Process Validation, Sterilization Validation) - Collaborate with the R&D team to review and approve DHF documents including Design Input - Design Output Matrix, Design Verification Test Protocols and Reports, Risk Analysis, DFMEAs, PFMEAs, and Process Validation Plans and Reports.
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Research & Development SpecialistAgile Mv Aug 2014 - Apr 2016Montreal, Canada Area- Supported implementation of ISO 13485 Quality Management System
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Research & Development SpecialistBavaria Medical Technology, Canada Inc. Nov 2010 - Aug 2014Boucherville, Quebec, CanadaDesign and development of medical devices for cardiology interventions- Built prototypes for pre-clinical testing and design verification- Developed design verification test protocols- Participated in risk management activities including DFMEA analysis- Supported implementation of ISO 13485 Quality Management System
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Mechanical Design InternMitec Telecom May 2007 - Apr 2008
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Intern - Engineering And Operations SupportSanjel Corporation May 2006 - Aug 2006
Jennifer Robb Education Details
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Mcgill UniversityMechanical Engineering -
Mechanical Engineering
Frequently Asked Questions about Jennifer Robb
What company does Jennifer Robb work for?
Jennifer Robb works for My01
What is Jennifer Robb's role at the current company?
Jennifer Robb's current role is Director of Quality.
What is Jennifer Robb's email address?
Jennifer Robb's email address is jr****@****emv.com
What schools did Jennifer Robb attend?
Jennifer Robb attended Mcgill University, Mcgill University.
Who are Jennifer Robb's colleagues?
Jennifer Robb's colleagues are Daniel Khodiienko, Maneesha Kalahe, David Morin, Maneesha Kalahe, Sara Kassab, Phil Walsh, Chrouk Kasem.
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