IBM Watson Health - Quality Analyst, Merge Healthcare in TORONTO, Ontario

Who is Merge Healthcare? Merge, an IBM company, is a leading provider of innovative enterprise imaging, interoperability and clinical solutions that seek to advance healthcare. Merge’s enterprise and cloud-based technologies for image intensive specialties provide access to any image, anywhere, any time. Merge also provides intelligent solutions and software for clinical trials. Visit and follow us @MergeHealthcare. Essential Responsibilities:

  • Works in conjunction with team members to develop, implement, and maintain the corporate quality system.

  • Ensures that the quality system is established, implemented, and maintained in accordance with the requirements established by FDA and other regulatory agencies. Includes ensuring conformance to industry and international standards as applicable and appropriate.

  • Participates in the internal audit program to assure ongoing compliance. Conducts audits as lead and/or supporting auditor per the audit schedule.

  • Directs the complaint handling program to ensure complaints are identified, processed, and investigated per internal procedures and regulatory requirements.

  • Oversees all activities related to the corrective and preventative action (CAPA) process. Tracks CAPA investigations through completion, implementation, and verification to ensure identified non-conformances are corrected and recurrence prevented.

  • Assists with supplier qualification, including participation in desk and/or on-site audits of suppliers as required.

  • Participates in FDA and other regulatory inspections.

  • Generates and presents reports for Management Reviews at prescribed intervals.

    Desired Skills:

  • Must be well versed in the medical device quality system regulations with experience in a quality and/or regulatory department within the medical industry.

  • Specific experience with software medical devices desired. Excellent communication and interpersonal skills are essential.

  • Willingness to handle day-to-day quality system issues by taking an active role in defining issues and proposing solutions.

  • Understands and implements the quality system in accordance with FDA QSRs, ISO 13485, MDD, and CMDR.

    This role will involve working with technology that is covered by embargo Export Regulations. If you are a Foreign National from any of the following embargoed countries (Cuba, Iran, North Korea, Sudan, and Syria) on a work permit, you are not eligible for employment in this position.CSUSWDevSupport

  • BA/BS in a scientific discipline or related equivalent experience

  • At least 3 years experience in the medical industry including quality system audit experience.

  • Understands and implements the quality system in accordance with FDA QSRs, ISO 13485, MDD, and CMDR.

  • Travel: 10%