Quality Assurance Manager

4 weeks ago


Lincolnshire, Kentucky, United States Sysmex America Full time
Job Title: Quality Assurance Manager

About the Role:
Sysmex America is seeking a Quality Assurance Manager to oversee and manage the quality of product and process at our facility. The successful candidate will ensure quality management systems processes are adhered to in accordance with established Good Manufacturing Practices (GMP), ISO, and applicable regulatory requirements.

Key Responsibilities:
• 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.

Requirements:
• Bachelor's degree in a 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.
• ASQ or other industry certifications are a plus.
• 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.

About Sysmex America:
Sysmex America is a leading provider of diagnostic equipment and information-management systems. We are committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis, and life sciences for the clinical laboratory. Our agile, resourceful team is dedicated to enhancing the quality of life on a global scale.

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