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**Job Function: **
Quality
**Job Sub Function: **
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Chuo-ku, Tokyo, Japan
Job Description:
Essential Job Function
Responsible for maintaining the Quality Management System (QMS) in compliance with MHLW ordinance No 169 (QMS ordinance) and other regulatory requirements.
Ensure Quality Management System procedures are established and maintained in compliance to International, National and Local regulatory requirements and company’s policies.
Identify changes to relevant regulatory requirements and industry standards
Undertake gap assessment activities to newer regulatory requirements
Work cross functionally to address the identified system gaps and implement changes
Train the organization to ensure the new requirements are communicated internally
Manage the NCR process
Administer and manage the NCR process and maintain overall compliance to relevant procedures
Collect and analyze data from various processes (NCRs) for periodic reviews
Coordinate with cross functional team members to collect relevant data and compile presentation for the reviews
Identify opportunities for improvement
Present the information at the periodic reviews Monitor and trend metrics
Identify and drive Quality Management System continuous improvement activities
Supplier Management
Define and implement processes which meet regulatory requirements pertaining to the selection, evaluation, and monitoring of suppliers
Create and/or maintain procedures to ensure that the organization complies with applicable regulatory standards
Identify supplier risks and work with cross-functional teams to prevent and/or resolve issues which could interrupt business continuity
Communicate critical issues to upper management and escalate accordingly
Oversee and manage the execution of Supplier Quality responsibilities such as Supplier Audits, Supplier Qualifications.
Schedule, plan and implement an effective internal and external Audit program.
Manage Document Control and Training system.
Other relevant duties as assigned undefined
Requirements
BS degree in a related discipline with 10+ years’ experience in medical device quality systems and compliance role
2 years of managerial experience or equivalent, relevant experience
Strong understanding of PMD Act and other International medical device regulations
Excellent written and verbal communication skills
Experience in supporting Regulatory Submissions
Strong front room audit experience with an ability to effectively present and defend quality systems under your responsibility and management
Proficiency in using Statistics, data compilation, analysis, presentation
Preferred
Project Management experience and excellent organizational skills is preferred
Remains current with regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings
Responsible for coaching, training and development of subordinates
Identifies and manages continuous improvement projects
Ability to work in a fast-paced environment while managing multiple priorities
Operate as a team and/or independently while demonstrating flexibility to changing requirements
**Required Skills: **
Preferred Skills:
Business Alignment, Coaching, Collaborating, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility