Manager, Quality Assurance / Quality Systems

Sysmex•Mundelein, IL

57d•$84,000 - $138,600

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. 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 systems processes are adhered to in accordance with established Good Manufacturing Practices (GMP), ISO, and applicable regulatory requirements. The manager is responsible ensuring the accurate and timely completion of Quality Management System 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 Quality team professionals responsible for monitoring day to day business activities, including review and approval of medical devices for product release.

Requirements

Bachelor’s degree in related field required.
Previous 5-8 years’ experience QA in a related industry required.
Knowledge of cGMP (FDA QSR) and ISO 13485 regulations is required.
Language skills: English
Microsoft Office Suite (Word, Excel, PowerPoint, 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 problems, gather relevant data, evaluate facts, and draw logical conclusions.
Effective teamwork and leadership skills.
Ability to make data-driven decisions for quality system performance.

Nice To Haves

ASQ or other industry certifications are a plus.
Familiarity with SAP S/4HANA, VEEVA, Global Trackwise are a plus.

Responsibilities

Lead QA team to support reagent production with Quality Management System.
Support SRA quality management systems activities including, but not limited to:
Document Control
Internal / External / Supplier / Customer Audits
Complaint Handling
Change Management: Design Change / Transfer
CAPA and NCR management
Product release activities
Tracking and Trending / Reporting
Risk Management
Provide quality review and approval of quality management system and reagent manufacturing process documents.
Oversee Supplier Quality Monitoring, escalating to SCARs when necessary.
Participate in Customer Complaint Investigations, ensuring 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.