Head of Quality Assurance Abbott Medical Japan

• Cardiac Rhythm Management (CRM)
• Electrophysiology (EP)
• Heart Failure (HF)
• Neuromodulation (NM)
• Structural Heart (SH Legacy SJM Products)

• Applicable regulatory requirements including Pharmaceuticals and Medical Devices Act (PMD Act)
• Applicable Quality requirements
• Business Requirements
• Global QMS strategy and Direction

• 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.

• 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.

• Supervise activities led by the Safety Management Officer.

• 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.

• 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.

• Basic PC skills (Excel Word PowerPoint);
• English communication skills;
• People management experience in a medium-sized or larger organization

• 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

In specific locations the pay range may vary from the range posted.