【非公開求人】【品質保証】日本QA組織の戦略とQMSを統括する責任者｜外資系企業｜東京｜フレックス

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.

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

完全週休2日制（土・日）、祝祭日、夏季休暇、年末年始、年次有休休暇、母性健康管理のための休暇（産前産後休暇・育児休暇・育児時間）等、子の看護休暇、介護休暇、生理休暇、誕生日休暇