Manager, Quality Engineering
Sysmex North America - Mundelein, IL
posted 4 days ago
About the position
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
- 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.
- Develop and maintain revalidation strategies to preserve the validated status of a process, equipment, and infrastructure.
- 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.
- Conduct risk assessments and develop mitigation strategies for process validation.
- Develop and maintain Standard Operating Procedures (SOP), Work Instructions (WI), and other related controlled documentation related to process validation, change management, and revalidation.
- Act as the subject matter expert (SME) for process validation and revalidation during internal and external audits.
- 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.
- Monitor and implement any regulatory changes, industry trends and advancements in process validation and revalidation methodologies.
- Foster collaborative environment with cross-functional teams across the Sysmex America businesses.
- Other duties as assigned.
Requirements
- 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.
- Proficient in 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.
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
