Sysmex America, Inc. · 4 months ago
Manager, IT Process Governance
US-IL-Lincolnshire
Full-time
Onsite
Senior Level, Lead/Staff
$100K/yr - $157K/yr
8+ years expSysmex America, Inc. is a leading company in innovative diagnostic equipment and information-management systems, headquartered in Lincolnshire, Illinois. They are seeking an IT Process Governance Manager to manage the standardization of IT product design, development, testing, implementation, and operations processes while ensuring compliance with regulatory requirements and industry best practices.
Health Diagnostics
Responsibilities
Responsible to 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. This includes managing change and alignment with cross-functional teams impacted by added or modified processes (Quality Assurance, Customer Care, Marketing, Customer Service, etc.)
Provides 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. This includes monitoring performance of projects as they enter and exit the Customer Systems & Innovations Project Management Office to identify and communicate continuous improvement opportunities for continued compliance
Responsible to 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 (FDA, ISO, MDSAP, HITRUST, etc.)
Acts as Business Owner for design, development and testing tools such as Jira, Confluence and qTest to monitor the technology strategy on digital workflow process. This includes coordinating system upgrades and maintenance to ensure systems are maintained at a supported level and remain operational
Coordinates with IT Data Analysts to establish and maintain standardization across Customer Systems & Innovations organization on the use of design, development and testing tools. This includes development and monitoring of key performance indicators to support quality metrics for design, development and testing processes
Responsible to identify, solution, socialize and manage change of process improvements to support design, development and manufacturing processes for the Customer Systems & Innovations organization
Responsible to maintain business partnership with Sr. Manager, PMO to ensure continuous alignment between PMO and IT Governance teams. This includes collaboration on process improvement initiatives to continue to create efficiencies and mature the organization
Perform manager-type responsibilities for direct reports (performance management, time reporting, expense management, etc.)
Other duties as assigned
Qualification
Required
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
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
Preferred
Master's degree preferred
Benefits
Health care plan (medical, vision, and dental insurance)
Annual incentive bonus
Paid time off
Parental leave
Bereavement leave
401(K) for all eligible employees
Company
Sysmex America, Inc.
Sysmex America, Inc.
1001-5000 employees
H1B Sponsorship
Sysmex America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (11)
2024 (3)
2023 (5)
2022 (7)
2021 (5)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
unknown1996-07-25IPO
Leadership Team
Andy Hay
Chief Executive Officer
Chris Cappella, CPA
Chief Financial Officer
Recent News
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