About this role
JOB DESCRIPTION: The Head of Quality Assurance Japan sets direction and strategy for the Japan QA team, supporting the following Business Units:
• Cardiac Rhythm Management (CRM)
• Electrophysiology (EP)
• Heart Failure (HF)
• Neuromodulation (NM)
• Structural Heart (SH – Legacy SJM Products)
The Head of Quality Assurance Japan is responsible for the implementation and maintenance of an effective Quality Management System, compliant with:
• Applicable regulatory requirements, including Pharmaceuticals and Medical Devices Act (PMD Act)
• Applicable Quality requirements
• Business Requirements
• Global QMS strategy and Direction
Major Responsibilities
General / Quality Management
• Budget management and resource allocation
• Goal setting, commitment and performance evaluation of staff
• Competency requirements, training plans, execution and effectiveness evaluation
• Leading continuous improvement activities.
Compliance
• Oversee Quality Management System (QMS) activities and Manufacturing control activities under the direction of Domestic Quality Assurance Manager
• Oversee warehouse activities, Quality control and Labeling.
Safety
• Supervise activities led by the Safety Management Officer.
Continuous Improvement
• Supports cross-functional improvement initiatives
• Process improvements for QMS effectiveness and PMD Act compliance,
• Follow-up of audit observations/nonconformities
• Participation in new process launches and projects.
Minimum Requirements
Education
• Degree or specialized coursework in physics, chemistry, metallurgy, electrical engineering, mechanical engineering, pharmacy, medicine, dentistry, linguistics, or equivalent; alternatively
• At least three years of experience in medical device quality management or post-marketing safety.
Background:
• Basic PC skills (Excel, Word, PowerPoint);
• English communication skills;
• People management experience in a medium-sized or larger organization
Preferred Requirements
• Knowledge of medical device regulatory requirements, ISO 13485 or ISO 9001, or completion of related training;
• Experience as auditee during regulatory inspections;
• Project management experience
The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. JOB FAMILY: Engineering DIVISION: EP Electrophysiology LOCATION: Japan > Tokyo : Hamarikyu Park Side Place 9F, 17F 5-6-10,Tsukiji,Chuo-ku ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable