Manager, Quality Engineering - Sysmex

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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 for a Quality Engineering Manager. The Manager, Quality Engineering will oversee the validation and change control processes for equipment, infrastructure, and processes used in the manufacture, storage, and distribution of products. Reporting to the Director, QA Design Control & Validation Compliance, this role involves leading a team of Quality Validation Engineers and Specialists to ensure adherence to regulatory and industry standards. The Manager will drive compliance for Process Validation, Revalidation processes and Change Management, ensuring alignment with best practices and regulatory requirements.

1. In compliance to policy, regulatory requirements and industry standards, manage the engineering change control process to ensure all changes are assessed for impact on validated systems. Lead the Validation Review Board and manage the escalation process for validation exceptions.
2. Develop and maintain revalidation strategies to preserve the validated status of a process, equipment, and infrastructure.
3. Oversee the development, review, and approval of protocols and reports for Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Revalidation activities.
4. Conduct risk assessments and develop mitigation strategies for process validation.
5. Develop and maintain Standard Operating Procedures (SOP), Work Instructions (WI), and other related controlled documentation related to process validation, change management, and revalidation.
6. Act as the subject matter expert (SME) for process validation and revalidation during internal and external audits
7. Identify and implement opportunities for process improvements to enhance efficiency and compliance presenting Key Performance Indicators (KPIs) to senior management to track and improve process performance.
8. Monitor and implement any regulatory changes, industry trends and advancements in process validation and revalidation methodologies.
9. Foster collaborative environment with cross-functional teams across the Sysmex America businesses.
10. Other duties as assigned.

Percentage of Travel: 10%

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.

• Bachelor’s degree or higher and 8 years’ experience in process validation or 10+ years job experience within the medical device or pharmaceutical industry, including experience in the Armed Forces.

• In-depth knowledge of FDA, ISO 13485, and other relevant regulatory requirements.

• English

• Microsoft Word, Outlook, Excel, PowerPoint, Access, Internet, Veeva Vault

• Proven experience managing FAT, SAT, IQ, OQ, and PQ protocols.

• Strong leadership and time management skills.

• Excellent problem-solving and analytical abilities.

• Effective communication and presentation skills.

• Proficient in validation lifecycle management and change control processes.

• Strong ability to understand and convey complex technical information.

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.