Jennifer Robb Email & Phone Number

Canada

Montreal, 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

Montreal, 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

Montreal

- 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

Montreal, 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.

Montreal, Canada Area

- Supported implementation of ISO 13485 Quality Management System

Boucherville, Quebec, Canada

Design 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

M. Eng., Mechanical Engineering

Thesis Title: Evaluation of Contact Pressure in Human Vocal Folds During Phonation Using High-Speed Videoendoscopy

B. Eng., Mechanical Engineering