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Abbott Rapid Diagnostics Medical Co., Ltd is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

We supplies variety of rapid diagnostics products through out the world, EU, Asia, Canada and Japan. All of the products are designed, manufactured and released by us.

The position of Quality Compliance Manager , is within our Abbott Rapid Diagnostics Medical Co., Ltd, located at Matsudo, Chiba (Chiba Plant). Due to portfolio of our products, Chiba plant is compliant with regulations throughout the world (except US), not just Japanese regulations.

This position provides quality oversight and leadership by proposing and implementing process improvements and maintaining and improving various quality system processes. Train others and advance the state of each regulatory requirements and compliance knowledge of the organization.

Support projects to be completed within time and in full and in compliance with all relevant regulatory requirements. Establish plan to meet department goals, compliant with site level policies and procedures, aligned with the quality system and consistent with regulatory requirements and business objectives.

This job function has accountability for complying with the applicable elements of Global Quality and the Quality Management System (QMS).

This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:

• Work on maintaining and improving the Quality Management System (QMS) to comply with compliance. Identify key process indicators, monitor and analyze, and support to report to management.

• Conduct and manage external and internal audits. Support to report the audit results to management and execution of corrective actions associated with the audit results.

• Work on maintaining and improving the document management system and document change management process, such as building effective document structure, new document issuance, revision and obsoletion, document review, approval, issuance and effective of document in order to comply with applicable standards/requirements.

• Work on maintaining and improving the education and training system to ensure proper product quality and meet applicable standards/requirements. This activity includes developing and implementing a continuous training plan to improve awareness of the Quality Management System. Assign training programs through the training system as needed and support employees to complete their assigned training programs on time.

• Work on maintaining and improving supplier management system, meet applicable standards/requirements and develop high responsive supplier issue management system. Manage supplier issues timely with local and global suppliers, and escalate issues timely to global supply management team.

• To achieve Quality Goals consistent with each quality system, implement concrete plans with clear milestones and lead the plan within the site.

• Manage performance of quality engineers/specialists towards department and company goals, including feedback on performance, appraisals, coaching, talent management, open communication etc.

BASIC QUALIFICATIONS | EDUCATION:

• Bachelor's degree in areas such as medical, engineering, science and chemistry.

• 5 plus years of experience in the medical device, diagnostic products or pharmaceutical industry.

• Work experience in manufacturing environment such as Quality Assurance, Quality control, Manufacturing, Engineering etc.

• Skill and work experience establishing quality systems in manufacturing environment, meeting domestic and global requirements, and also managing the same system .

• Knowledge, skills and work experience of improvement process.

• Flexibility to adapt to any changes and ability to effectively prioritize.

• Excellent written and verbal communication skills. Japanese and English reading, writing and speaking ability.

PREFERRED QUALIFICATIONS:

• Understanding of ISO 13485, MDSAP, IVDD/IVDR, In-Vitro Diagnostic Drug Manufacturing License, requirements and product development.

• Process Excellence certified (Green Belt / Black Belt).

• Analytical/Problem Solving Skills (e.g. DMAIC, statistical techniques, risk analysis).

• Knowledge EU, Asia, Japan regulatory requirements.

COMPETENCIES:

• Language Competencies : Japanese and English verbal communication.

• Drives for Results: Leverages resources, tools and technologies in order to progress more effective and efficient.

• Fosters Collaboration: Avoids getting stuck in a “one right way” approach and remains open minded to new ideas. Actively develops a network to bring best solutions to the team or customer.

• Provide mentoring in quality, compliance, and technical areas across multiple work groups.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com