Sysmex America, Inc. · 1 day ago
Manager, Quality Assurance / Quality Systems
Mundelein, IL
Full-time
Onsite
Mid, Senior Level
$84K/yr - $139K/yr
5+ years expSysmex America, Inc. is a leading company in diagnostic equipment and information-management systems, headquartered in Lincolnshire, Illinois. They are seeking a Manager, Quality Assurance / Quality Systems to oversee and manage the quality of product and processes, ensuring compliance with established Good Manufacturing Practices and regulatory requirements.
Health Diagnostics
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
Qualification
Required
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
Preferred
ASQ or other industry certifications are a plus
Familiarity with SAP S/4HANA, VEEVA, Global Trackwise are a plus
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
Company
Sysmex America, Inc.
Sysmex America, Inc.
1001-5000 employees
H1B Sponsorship
Sysmex America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (3)
2023 (5)
2022 (7)
2021 (5)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
unknown1996-07-25IPO
Leadership Team
Andy Hay
Chief Executive Officer
Chris Cappella, CPA
Chief Financial Officer
Recent News
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