[Quality] Manager Quality Assurance [Shockwave]

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com.

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:

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