Sysmex-posted 4 months ago
$100,100 - $157,300/Yr
Full-time • Manager
Buffalo Grove, IL

Find a Better Way... to use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way. Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.

  • Provide consultation services to leadership on design/development and quality assurance policy, procedure and implementation to ensure compliance with regulatory requirements, Customer Systems & Innovations standards and industry best practices.
  • Provide direction and strategy to Analysts, IT Governance to consult, review and ensure compliance with Sysmex Product Design and Development Process (PDDP) and Customer Systems & Innovations standards as independent reviewers.
  • Act as subject matter expert on design, development and manufacturing of medical device products and supporting quality systems on behalf of Customer Systems & Innovations teams to support internal and external audits.
  • Act as Business Owner for design, development and testing tools such as Jira, Confluence and qTest to monitor the technology strategy on digital workflow process.
  • Coordinate with IT Data Analysts to establish and maintain standardization across Customer Systems & Innovations organization on the use of design, development and testing tools.
  • Identify, solution, socialize and manage change of process improvements to support design, development and manufacturing processes for the Customer Systems & Innovations organization.
  • Maintain business partnership with Sr. Manager, PMO to ensure continuous alignment between PMO and IT Governance teams.
  • Perform manager-type responsibilities for direct reports (performance management, time reporting, expense management, etc.).
  • Other duties as assigned.
  • Bachelor’s degree required.
  • 8+ years of previous experience in People and/or Process Management, QA and/or Compliance, QA Software Engineer, Business Analyst, Application Testing Processes required.
  • Master’s degree preferred.
  • Working knowledge of ISO framework for Product Design & Development Processes for cloud application services.
  • Hands-on experience with audit preparation and running audit sessions for FDA, ISO and/or Security audits.
  • Proven ability to work under stress in emergencies with flexibility to handle multiple high-pressure situations simultaneously.
  • Proven leadership abilities including effective knowledge sharing, conflict resolution, facilitation of open discussions, fairness and displaying appropriate levels of assertiveness.
  • Ability to communicate highly complex technical information clearly and articulately for all levels and audiences.
  • High critical thinking skills to evaluate alternatives and present solutions that are consistent with business objectives and strategy.
  • Must demonstrate initiative and effective independent decision-making skills.
  • Office Suite (Word, Excel, PowerPoint, Outlook).
  • Atlassian Suite (Jira, Confluence, Zephyr).
  • Tricentis qTest Suite.
  • Proven success in leading a team of resources in a high paced environment to meet simultaneous critical deliverables.
  • Working knowledge of Agile methodology and software testing strategies.
  • Choice of health care plan (medical, vision, and dental insurance).
  • Annual incentive bonus.
  • Paid time off.
  • Parental leave.
  • Bereavement leave.
  • 401(K) for all eligible employees.
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