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Quality Engineer

$75k - $85k

ClifyX

Quality Engineer

Role: Quality Engineer

Duration of the requirement: 24 months

Number of position: 1

Project Start Date: 19th Mar 2018

Compensation: Between: 75-85K USD per year

Please do not submit any resumes above $85k

Must Have Skills
  • A Bachelor's Degree in an Engineering or Scientific discipline. An Advanced Degree in a related field is an asset.
  • A minimum of 4-5 years' experience in Post Marketing Surveillance for highly regulated industry.
  • A minimum of 2 years in Medical Device / Diagnostic / Pharmaceutical industry
  • Experience in complaint handling, DFMEA, MDR & strong knowledge in Microsoft excel.
  • Strong Presentation skill
  • Excellent Interpersonal skills that foster conflict resolution as it relates to technical situations
  • Ability to collaborate with business partners at all levels across multiple functional groups
  • Knowledge of process and design excellence tools
Good To Have Skills

Minitab experience is preferred

Six Sigma Green or Black Belt preferred

Prior experience leading teams and/or projects

Key Responsibilities
  • Perform post-market safety and surveillance activities
  • Systematic collection, analysis and evaluation of product safety and performance data
  • Conduct trend analysis, signal detection and product investigations with the focus on early warning of patient safety & product quality issues
  • Get complete understanding of the current risk profile of our products while assessing the overall risk/benefit of the product
  • Review and update risk management files for completeness and accuracy
  • Lead & support corrective and preventative actions to address product issues and facilitate field actions
  • Support quality system activities - Complaint Investigations, Internal Audits, and third party inspections
  • Interface with key business partners all levels across multiple functional groups including R&D, Operations, Medical and Marketing, Quality & Regulatory Compliance group
Vacancy posted 2 days ago
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