Manager, Quality Assurance​/Quality Systems

Overview

Manager, Quality Assurance / Quality Systems at Sysmex America, Inc. The Manager oversees and manages the quality of product and process for Sysmex Reagents America, Inc. (SRA). This role ensures quality management systems processes are adhered to in accordance with established GMP, ISO, and applicable regulatory requirements.

• 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.

• Bachelor’s degree in related field required. 5-8 years’ QA experience in a related industry required.
• Knowledge of cGMP (FDA QSR) and ISO 13485 regulations is required.
• ASQ or other industry certifications are a plus.
• 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.
• Familiarity with SAP S/4
  
  HANA, VEEVA, Global Trackwise are a plus.
• Effective teamwork and leadership skills.
• Ability to make data-driven decisions for quality system performance.

The salary range for this role is $84,000-$138,600. Within this range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. The total compensation package for this position also includes a choice of health care plan (medical, vision, and dental insurance), an annual incentive bonus, paid time off, parental leave, bereavement leave and a 401(K) for all eligible employees.

Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status or protected veteran status.

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Full-time
• Job function:
  Quality Assurance
• Industries:
  Medical Equipment Manufacturing