[Quality] Manager Quality Assurance [Shockwave]
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Chuo-ku Tokyo JapanJob 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 companys 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 inmedical 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 CredibilityRequired Experience:
Manager
Key Skills
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
