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/A
In 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
