Quality Assurance Analyst II - Mississauga

Only for registered members Mississauga, Canada

2 weeks ago

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job summary

at boston scientific we value collaboration and synergy this role follows a hybrid work model requiring employees to be in our local office at least three days per week

responsibilities

  • review complaint communications and assess complaints for regulatory reportability and potential impacts to patient safety and business operations
  • apply clinical knowledge as related to product usage to evaluate complaints investigate complaints by gathering sufficient data from clinical staff field representatives internal employees laboratory analysis results and other relevant sources establish regulatory reportability decisions using event investigation and regulatory decision models participate in development modification of these decision models with changes in product advances therapies to uphold consistent compliance with government mandated regulations write medical device reports mdrs vigilance other regulatory reports ensuring timely submission to appropriate regulatory authorities accurately consistently apply codes events review coding investigations engineering laboratory internal staff applicable effectively compose written communication detailing clinical observations investigations analyses corrective actions applicable physicians end use customers

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