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SECTION 1: JOB SUMMARY*

The Sr. Quality Operation Engineer/Specialist will oversee and execute all activities related to Quality Operations. This role is crucial in ensuring that the company's products and processes comply with both internal and external quality standards, as well as regulatory requirements. The individual in this position will play a vital role in maintaining the integrity of the Quality Management System and supporting continuous improvement initiatives at third-party logistics (3PL) providers and distributors. The Sr. Quality Operation Engineer/Specialist will report directly to the Sr. QA Manager. 

Section 2: DUTIES & RESPONSIBILITIES*

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

·       Leads all product-related Quality Notifications (QNs) and their investigation by collaborating with the US team. 

·       Addresses customer-impacting issues and prioritizes solutions that focus on quality and compliance. 

·       Responsible for the timely closure of product-related QNs and Corrective and Preventive Actions (CAPAs). 

·       Manages incoming inspections, product releases, and storage-related activities in third-party logistics (3PL). 

·       Develops and improves processes within the 3PL and distributors to enhance efficiency and quality management. 

·       Improves key Quality Management System (QMS) processes, including Nonconformance Management and CAPAs. 

·       Oversees the calibration and management of measuring equipment used by QA to ensure compliance with quality standards. 

·       Responsible for communicating business related issues or opportunities to next management level

·       Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

·       For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

·       Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Performs other duties assigned as needed

SECTION 3: EXPERIENCE AND EDUCATION*

• A minimum of 3 years of experience in Quality Assurance within the medical device industry or a related field. 

• Fundamental knowledge of the Japan PMD Act, QMS Ordinance, and ISO 13485:2016 standards. 

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

·       Basic analytical and problem-solving skills. 

·       Strong communication and interpersonal skills to effectively collaborate with cross-functional teams. 

·       Fluency in Japanese and basic proficiency in English for both writing and verbal communication. 

·       Basic PC skills, including proficiency in Excel, Word, PowerPoint, and PDF software. 

＜ For Internal Applicants＞

• If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.
• For Employee Referral Program (ERP), please read and understand the details of the “Employee Referral Program (ERP)” on the AskGS and you have made a compliant referral.

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