Quality Assurance Analyst (BB-FF38F)

Encontrado en: Neuvoo AR



  • Review complaints and determine eligibility for adverse event reporting
  • Evaluate and track complaints through complaint process workflow to closure
  • Coordinate complaint closures per established business metrics.
  • Ensure completeness of complaint files prior to closure
  • Collaborate with a variety of diverse persons such as Engineers, Scientists, Clinical Specialists, Field Service Engineers, Professional Customers and Manufacturing personnel to facilitate the complaint investigation process globally.
  • Assist with internal/external audits in support of complaint handling, document control, supplier quality and training activities
  • Compile complaint trends for management review and support of product reliability reviews
  • Coordinate and compile department metrics to support management review meetings
  • Process change orders for new and revised documents including engineering, manufacturing and quality system documents
  • Coordinate the change control function for product improvements and new product development
  • Ensure all document changes are processed
  • Manage distribution and archiving of controlled documents and records in compliance with PerkinElmer procedures
  • Ensure superseded documents are removed from use.
  • Create or revise documents in support of system, product or process changes.
  • Collaborate with site management to develop training curricula and ensure personnel are appropriately assigned to curricula
  • Provide summary reports for training compliance to site management
  • Compile department metrics and report metrics to management via reports and/or review meetings.
  • Assist with the qualification of new suppliers and communicate to teams as necessary
  • Request supplier documentation, maintain approved supplier lists for qualified suppliers, update supplier records and communicate to teams as necessary
  • Provide data regarding quality performance analysis and reporting for suppliers
  • Schedule and prepare meeting agendas for Global Change Control Board.
  • Generate and distribute Change Control Board meeting minutes.
  • Job Qualifications:

  • Bachelor Degree in Life Sciences or equivalent work experience .
  • 5-8 years of experience in related disciplines within the medical device or pharmaceutical industry.
  • Strong data analysis skills and proficiency in electronic data management systems.
  • Fluent in English, Spanish, Portuguese
  • Preferred Job Qualifications:

  • Ability to work in a matrixed organizational structure, developing strong relationships with multi-national business partners
  • Exceptional attention to detail
  • Ability to take direction and multi-task in a fast-paced environment
  • Ability to work independently with minimal supervision
  • Strong data analysis skills and proficiency in electronic data management systems
  • Superior interpersonal, verbal and written communication skills
  • Exceptional organizational, negotiation, and problem-solving skills
  • If you are interested in applying for this role, please submit your resume in English.

    calendar_todayhace 2 días

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    info Full time

    location_onBuenos Aires, Argentina

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