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Soundbite Medical Solutions

Quality Inspection Technician

Quality Engineering · Saint-Laurent, Quebec
Department Quality Engineering
Employment Type Full-Time
Minimum Experience Entry-level

SoundBite Medical Solutions Inc. is developing proprietary shockwave technology to address significant unmet clinical needs in interventional vascular treatment. Through an elegant combination of hardware and software, it can, in a very controllable manner, deliver high amplitude shock wave pulses through guidewires and other interventional tools, to specifically attack highly calcified and fibrotic tissue in the vascular system, while leaving healthy, elastic arterial walls unharmed.

 

We are currently seeking a Quality Inspection Technician to join our team based in the Montreal Office on a full time basis. As a Quality Inspection Technician, your primary responsibility will be to apply your expertise and knowledge in order to plan and conduct activities to improve and assure quality design and manufacturing of medical devices and components.

 

The Quality Inspection Technician will be responsible for:

 

  • Executing inspection requirements and inspection plans;
  • Executing and reporting incoming inspection and evaluation of all finished devices or device components;
  • Performing sampling, testing and inspection for the final release of devices;
  • Marking, tagging and isolation (quarantining) any defective material/ products and issue NCR and follow up on disposition;
  • Managing DHR (Device History Record);
  • Following up on clean room parameters;
  • Collecting and recording all supplier’s certificates and records for incoming final devices or device components;
  • Supporting the design of bench testing;
  • Supporting the establishment of inspection & test methods;
  • Participating in the execution of testing as part of the Product Design Verification & Validation Test Plan;
  • Support establishing & executing calibration master plan;
  • Participating in investigations: NCM System, Deviation System, CAPA System, etc.;
  • Ensuring other project activities as assigned by the Quality Specialist, Disposables & Systems.

  Qualifications & Education Requirements

 

  • DEC III in Engineering Technologies and/or equivalent relevant experience;
  • 1+ years technical experience in medical device design/manufacturing or similar;
  • Experience in Quality Control/Assurance;
  • Good manual dexterity and keen eyesight to manipulate small components;
  • Detail Oriented;
  • Strong technical writing skills
  • Knowledge of ISO 13485 quality system is considered an asset;
  • Critical mind, initiative, resourceful, autonomous, driven, team player and leadership;
  • Ability to analyze data and write technical documents;
  • Strong interpersonal skills;
  • Ability to work autonomously on several projects;
  • Excellent communications and organizational skills;
  • Bilingual (French and English);
  • Eager to learn in a fast-paced environment;
  • Advanced MS Office skills and SolidWorks (or similar);
  • Experience with Matlab and/or Python (or similar) is a plus.

This position reports to the Quality Specialist, Disposables & Systems

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  • Location
    Saint-Laurent, Quebec
  • Department
    Quality Engineering
  • Employment Type
    Full-Time
  • Minimum Experience
    Entry-level