Director, Software Design Control & Validation at Sysmex America

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...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. 

We currently have a great opportunity available for a Software Design Control & Validation Director. The overall purpose of this position is to effectively manage day-to-day Software Quality Assurance Validation activities, resource planning of onshore and offshore Software Validation Engineers, and management of software validation support activities for various product validations for the Sysmex America Inc (SAI) and Sysmex Reagents of America (SRA) businesses.  This position will support the Regulatory Department in providing software validation documentation as needed for the regulatory submission paperwork and participate on new product launch teams as needed.

Essential Duties and Responsibilities:

1. Ensure compliance of Sysmex businesses, including FDA, ISO, and Health Canada / Canadian Medical Device Regulations.
2. Responsible for all software validation-related activities associated with Sysmex businesses including, but not limited to, new factory equipment, infrastructure and processes, SAI IVD and Health IT products and Corporate Support Systems such as CRM, ERP and other internal /” home grown” systems used to support the sales, service and supply chain activities of the Americas business.
3. Provide strategic quality planning, representation and guidance at New Product Launch teams for Quality Systems-related topics, as required.
4. Manage the Change Approval Board for product design changes, ensuring changes are validated, have record of change, and the impact of change is understood related to other products and the overall interoperability of the networked system.
5. Provide Product Design and Development Process training, Independent Reviewer mentoring, and support FDA inspection activities as needed.    
6. Participate in and facilitate (as required) FDA, HC, ISO, Customer, Supplier audits, and Regulatory inspections Have knowledge of department and corporate procedures and processes to demonstrate compliance to Regulatory bodies.
7. Support development of continual improvement activities from a Design Control and Validation Services perspective. Maintain clear, concise and accurate files of Validation documentation to support Regulatory and Compliance-related inspections.
8. Drive cross functional culture change in the adoption of Design Control and Validation processes, as well as compliant record keeping in support of software products. Includes adoption of Design Control and Validation process requirement across the Sysmex Corporate network. 
9. Provide Quality oversight and guidance to Sysmex’s Marketing & Promotional materials to ensure compliance with FDA labeling guidelines and requirements.
10. Responsible for performing impact analysis and managing through potential field safety issues related to software product defects.

Physical Risk: Regular exposures to risk that may require special training and precautions.

Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.

Percentage of Travel: 10 – 15%

• Bachelor’s Degree in Science with at least 15 years’ experience in medical device industry, working within quality system framework for software design controls and validation.
• Knowledge of cGMP (FDA and HC QSR) and ISO regulations.
• English 
• Microsoft Word, Outlook, Excel, PowerPoint, Access
  
• In depth understanding of Design Controls and Validation requirements in support of Software products. Strong communication and interpersonal skills. Ability to obtain cooperation, develop a consensus and lead or influence cross-functional teams.
• In conjunction with Corporate staff, develop and formulate final decisions on key regulatory and compliance issues affecting Sysmex products, services and customer support issues. Manage departmental budget and objectives to achieve business goals and project timelines.
• Must be able to assimilate relevant technical, regulatory and compliance information and formulate suitable strategies and tactics to satisfactorily resolve complex problems.
• Strong practical knowledge of compliance and regulatory environments. Knowledge of hematology products and marketplace preferred but not required.
  

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.