Head of Quality Assurance - Abbott Medical Japan

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