Failure Investigation Engineer - Project Coordinator

•    Develop and execute various design verification activities on complex circuit boards.
•    Ensure appropriate documentation is transferred to product line specific areas. 
•    All activities must be performed in compliance with the Quality System
•    Perform duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
•    Set up and operate test equipment to evaluate the performance of developmental parts, assemblies, or systems under various use conditions, and record results diligently.
•    Collaborate within the department and cross-functionally to identify, define, and solve problems to satisfy user and business needs.
•    Author, modify or interpret test reports, status reports. 
•    Review designs or specifications for completeness, accuracy, adequacy, and compliance with company and/or customer specifications.
•    Troubleshoot equipments from the field and collaborate from cross functional teams.
•    Update complaint record documentation
•    Maintain complete and up to date procedures and work instructions.
•    Manage incoming inventory in laboratory and adjust sampling plan by region as needed.
•    Stakeholder management
•    Preparing status reports and publishing the weekly progress reports to senior management.

Physical Demands:
•    Ability to adhere to Decontamination lab gowning policy (Personal Protective Equipment)
•    Able and willing to work in potential biohazard environment.
•    Ability to lift and carry objects weighing 55 lbs. or less.
•    Ability to push and pull objects weighing 65 lbs. or less.
•    Ability to perform bending, squatting, sorting, and reaching to both ground level and overhead.
•    Ability to hold and grip objects.
•    Ability to see the letters and numbers on a personal computer screen, memos, reports, and other documents as well as projected slides on a screen.
•    Ability to work in a lab environment, including in front of a computer, at a work desk.
•    Requires moderate right- and left-hand coordination for the use of the personal computer.

Experience: 
•    5-7 years of experience in a quality lead role / project coordinator.
•    General understanding of QSR, ISO 13485 knowledge is an asset.
•    Experience using laboratory test equipment/tools and systems required.
•    Experience in Medical Device or Regulated industry preferred.

Desirable Qualifications:
•    Basic understanding of FDA 21 CFR 820 an asset
•    Exposure to Good Documentation Practices (GDP) an asset

Other Particulars:
•    Clear and effective oral communication skills
•    Proficient writing skills
•    Strong attention to detail and follow up skills.
•    Ability to handle multiple priorities with tight deadlines.
•    Proficient in MS Office