Company:
Sysmex
Location: Lincolnshire
Closing Date: 20/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Overview:
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.
...to improve the lives of others.
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.
...to build a promising future.
Responsibilities:
We currently have a great opportunity available for a IT Process Governance Manager. Manager, IT Process Governance manages the standardization of the IT product design, development, testing, implementation and operations processes for all products under the Customer Systems & Innovations portfolio. This role is also responsible for consulting on all RA/QA documentation for Corporate Systems & Innovation to meet and maintain internal RA/QA and FDA requirements and will be a key participant as needed in external audits, including those performed by the FDA.
Essential Duties and Responsibilities:
1. 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.).
2. 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.
3. 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.).
4. 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.
5. 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.
6. Responsible to identify solutions, socialize and manage change of process improvements to support design, development and manufacturing processes for the Customer Systems & Innovations organization.
7. 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.
8. Perform manager-type responsibilities for direct reports (performance management, time reporting, expense management, etc.).
9. Other duties as assigned.
Travel Percentage: 10%
Qualifications:
Bachelor’s degree OR 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) or similar tools highly desirable
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
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
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.
...to improve the lives of others.
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.
...to build a promising future.
Responsibilities:
We currently have a great opportunity available for a IT Process Governance Manager. Manager, IT Process Governance manages the standardization of the IT product design, development, testing, implementation and operations processes for all products under the Customer Systems & Innovations portfolio. This role is also responsible for consulting on all RA/QA documentation for Corporate Systems & Innovation to meet and maintain internal RA/QA and FDA requirements and will be a key participant as needed in external audits, including those performed by the FDA.
Essential Duties and Responsibilities:
1. 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.).
2. 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.
3. 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.).
4. 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.
5. 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.
6. Responsible to identify solutions, socialize and manage change of process improvements to support design, development and manufacturing processes for the Customer Systems & Innovations organization.
7. 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.
8. Perform manager-type responsibilities for direct reports (performance management, time reporting, expense management, etc.).
9. Other duties as assigned.
Travel Percentage: 10%
Qualifications:
Bachelor’s degree OR 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) or similar tools highly desirable
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
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
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