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Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Chuo-ku, Tokyo, Japan

Job Description:

Position Overview

In compliance with MHLW ordinance 169 Quality Management System, MHLW ordinance 135 Good Vigilance Practice, FDA, European MDD/MDR & other International Regulations, the Safety Management Specialist will perform work under general management supervision. General scope of this position is to ensure compliance to the Complaints and Post Market Surveillance System with the responsibility of timely complaint initiation and initial assessment of regulatory reporting, complaint follow-up and collaboration with the cross-functional engineers and technicians for timely completion of the complaint investigation. The Safety Management Specialist will also be responsible for ensuring quality metrics are achieved. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Essential Job Functions

• Under guidance, ensure compliance of the Complaints System to internal requirements and Domestic and International Regulations.
  • Initiate complaints and ensure all required information are gathered and added to the complaint file in an accurate and timely manner.
  • Ensure effective management of the process for proper collection of complained products and their timely return to the United States.
  • Drive analysis of reported complaints and communicate findings to support product improvements and promote proper usage.
  • Communicate with Customers and Shockwave Medical Sales reps in a timely and professional manner to gather necessary complaint information.
  • Collaborate with the cross-functional engineers to ensure timely investigation and risk assessment of each complaint.
  • Complete adverse event reporting determinations per geography regulatory requirements for approved devices and make required records in a timely manner.
  • Escalate high risk incidents to management.
  • Complete MDR/ MDV reports in an accurate and timely manner and ensure they are submitted to the regulatory authorities within the required timeframe per applicable geography regulation.
  • Provide support of technical evaluations and investigational tasks to ensure complaints are investigated and closed in a timely manner.
  • Write up complaint investigations using concise and grammatically correct English which is appropriate for regulatory review.
  • Support events including evaluation of intake information to assess whether a complaint is warranted.
  • Ensure assigned complaint metrics are achieved (e.g. achieve target times for complaint initiation, reportability assessment, MDR/ MDV Reporting, and complaint closure.)
  • Ensure complaints are prioritized based on the patient outcome, regulatory reporting requirements, product, and compliance risk.
  • Participate in Customer and Shockwave Medical rep training to ensure compliance to Shockwave Complaints/Post Market Surveillance requirements.
  • Assist with reports on complaint trending, complaint metrics, post market surveillance activities, Periodic Safety Reports etc.
  • Participate in the summary and communication complaint trend data to cross-functional teams.
  • Ensure compliance to the Post Market Surveillance System
• Assist in continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting and Risk Management Systems.
• Participate in quality system activities such as CAPAs, DCOs, and support internal and external audits.
• Support company goals and objectives, policies, and procedures, QSR, and FDA regulations.
• Other duties as assigned.

Requirements

• Associate's degree with 4+ years of related quality experience or a Bachelor's degree with 2+ years of related quality experience.
• Experience with Medical Device Complaint handling, Post Market Surveillance and Regulatory reporting for Class II/III devices is required.
• Experience with FDA/ISO Audits, NCR, and CAPA experience is a plus.
• Proficiency in data compilation, analysis, presentation, and document writing skills.
• Excellent written and verbal communication skills.
• The ability to understand and follow QMS Procedures. (e.g., SOP and WI's)
• Proficient with computer-based applications (MS Word, MS Excel, MS PowerPoint).
• Strong interpersonal skills and ability to provide good customer service support.
• Strong time management skills and the ability to multi-task in a fast-paced environment.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Innovation, ISO 9001, Persistence and Tenacity, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy

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