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