Head of Quality Assurance - Abbott Medical Japan

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