Contact Poster

Important Safety Warning:

Avoid fraud by meeting all sellers in-person to pay for items. Kijiji does not offer any transaction or payment services. Read More Safety Tips

Date Listed 26-Nov-16
Address , Kitchener, ON,
View map

Company KELLY SERVICES (CANADA) LTD.
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 www.kellyscientific.com to learn more and view a full listing of our opportunities.

QUALITY SYSTEMS SPECIALIST - MEDICAL

REQUIREMENTS:


  • 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)
RESPONSIBILITIES:


  • 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)
CLICK HERE TO APPLY NOW
___________________
KELLY SERVICES (CANADA) LTD.
Sponsored Links:

My Favourites ()

Recently Added: