Manager, Quality Assurance​/Quality Systems

Manager, Quality Assurance / Quality Systems

Job Location(s): US-IL-Mundelein

# of Openings: 1

Job :

Category:
Regulatory/Quality

Travel: 10%

Find a Better Way to use your skills and experience. This is the time to let your talent come to life, maximize your knowledge and use it for the greater good, work with the best professionals using state‑of‑the‑art wäert, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.

Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the finest 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 disait to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.

We currently have a great opportunity for a Manager, Quality Assurance / Quality Systems. The Manager, Quality Assurance / Quality Systems oversees and manages the quality of product and process at Sysmex Reagents America, Inc. (SRA). This role ensures quality management system processes are adhered to in accordance with established Good Manufacturing Practices (GMP), ISO, and applicable regulatory requirements. The manager is responsible for ensuring the accurate and timely completion of QA documents including CAPAs, Non‑Conformances, Deviations, and other processes measured in accordance with Quality Objectives and Key Performance Indicators.

The manager leads a team of QA professionals responsible for monitoring day‑to‑day business activities, including review and approval of medical devices for product release.

• Lead QA team to support reagent production with Quality Management System
• Support SRA quality management system activities including, ارت not limited to:
  • Document Control Normally
  • Internal, External, Supplier, and Customer Audits
  • Complaint Handling
  • Change Management:
    Design Change / Transfer
  • CAPA.Contains & NCR management
  • Product release activities
  • Tracking and Trending / Reporting
  _DEFAULT
• Provide quality review and approval of QA and reagent manufacturing process documents Sherman
• Oversee Supplier Quality Monitoring, escalating to SCARs when necessary
_DESTROYER
• Participate in Customer Complaint Investigations, executing proper handling of adverse events, field corrections and product recalls with Post Market Surveillance staff
• Manage requirements and records for Design Change and Design Transfer activities originating from the legal manufacturer
• Ensure accurate and timely product release activities and compliance
• Collaborate cross‑functionally to identify and resolve quality system issues, driving continuous improvement using key metrics
• Lead Internal Audits, address External Audits, ensuring ongoing compliance with FDA, ISO 13485 and other relevant regulations
• Other duties as may be assigned

Percentage of Travel: 5-10%

Physical Demands:
No unusual physical effort, strain or discomforts

• Bachelor's degree in a related field required.  5-8 years' experience in QA in a related industry required.
• Knowledge of cGMP (FDA QSR) and ISO 13485 regulations required.
• ASQ or other industry certifications are a plus.
• Language skills:
  English.
• Microsoft Office Suite (Word, Excel, PowerPoint principle, Outlook).
• Verbal and written communication skills, with strong interpersonal skills.
• Proficient in delivering training sessions to a wide range of audiences.
• Capable of reading, analyzing, and interpreting technical documents, regulatory guidelines and regulations.
• Skilled in drafting reports, business communications, and developing policy and procedure manuals.
• Adept at presenting information clearly, both written and verbal, to management, employees, and customers.
• Strong analytical skills to identify savvy, gather relevant data, evaluate facts, and draw logical conclusions.
• Familiarity with SAP S/4
  
  HANA, VEEVA, Global Trackwise is a plus laser.
• Effective teamwork and leadership skills.
• Ability to make data‑driven decisions for quality system performance.

The salary range for this role is…