Senior Analyst, Quality Assurance (QMS Specialist)

Role Information

Beckman Coulter Diagnostics is seeking a Senior Analyst, Quality Assurance (Quality Management System Specialist) to join their Global Business QARA team. In this pivotal role, you will maintain and manage the Quality Management System (QMS) for our world-class medical diagnostic instruments manufactured at our Mishima site and exported globally.

What You Will Do

1. Lead Internal Audits: Act as a primary internal auditor to ensure the integrity and compliance of our Quality Management System.

2. Support External Audits: Provide critical support during regulatory and third-party audits.

3. Global Collaboration: Liaise with quality process owners at our U.S. headquarters to align global and local quality standards.

4. Continuous Improvement: Drive QMS process enhancements, including the creation of standard operating procedures (SOPs) and conducting employee training.

5. Management Reporting: Facilitate Quality System Management Reviews and quality meetings to communicate system performance.

6. Records Management: Oversee the maintenance and accuracy of vital quality records.

Essential Requirements

1. Education: Bachelor’s degree in a relevant field.

2. Experience: 5+ years of professional experience in the Quality field, specifically within the medical device or pharmaceutical industries.

3. Regulatory Knowledge: Strong understanding of the Japan PMD Act (Pharmaceutical Affairs Law), FDA QSR, and related international regulations.

4. Language Skills: Fluency in Japanese and intermediate proficiency in English (capable of reading, writing, and participating in global discussions).

5. Soft Skills: A critical thinker who is goal-oriented and comfortable expressing opinions in a collaborative environment.

Preferred Qualifications * ISO 13485 Lead Auditor certification.