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Date Listed 26-Nov-16
Address , Kitchener, ON,
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Job Type Please Contact

Kelly Scientific Resources (KSR) is a specialty service of Kelly Services, Inc., a leader in providing workforce solutions. Since its launch in 1995, KSR has provided staffing and placement services to a broad spectrum of industries, including biotechnology, chemical, consumer products, cosmetics, environmental, food sciences, medical/clinical, pharmaceutical, and petrochemical. Today, KSR leads the world in dedicated scientific and clinical research staffing. Visit to learn more and view a full listing of our opportunities.



  • 3+ years' experience in the medical device industry with emphasis on quality related activities, FDA-governed experience required
  • Bachelor's degree in Science or Engineering related field OR Technologist diploma with applicable experience
  • Working knowledge of ISO 13485, 21CRR Part 820 and Medical Device Regulations (FDA and MDD required, other international a plus)

  • Product release of medical devices and approve Device History Files/Device History Records
  • Coordinate and maintain the quality system records
  • Lead the internal or external changes and monitor implementation
  • Prepare Quality Plans and Gap Analysis
  • Conduct training for internal employees and contract manufacturers on 'Company' medical and Quality Systems Requirements
  • Participate in continuous improvement activities, corrective action planning and customer satisfaction initiatives
  • Administrator of the Quality Documentation System
  • Lead the validation process of the Quality Documentation System
  • Review CAPAs, NCRs, Deviations, and SCAR reports, and conduct CAPA Review meeting
  • Review and approve development documentation and records
  • Conduct quality audits
  • Evaluate supplier performance and maintain approved supplier list
  • Assist the Senior QA/RA Manager in managing the quality system as per the applicable standards and regulations
  • Independent investigation of pre-market and post market reports of product failures or complaints to ensure adequate investigation and reporting to engineering and regulatory bodies
  • Verify design transfer activities to ensure they are executed according to applicable procedures, standards and regulations
  • Actively participate in third party audits (eg. ISO 13485, FDA, Notified Body, Health Canada etc)
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