Head of Quality Assurance Abbott Medical Japan – Abbott

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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

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

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