Sr. QA Specialist (ADC Abbott Diabetes Care)

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were always looking towards the future anticipating changes in medical science and technology.

Working at Abbott

At Abbott you can do work that matters grow and learn care for yourself and family be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity working mothers female executives and scientists.

Diabetes

Were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were revolutionizing the way people monitor their glucose levels with our new sensing technology.

Main Purpose of the Role

As a Sr. QA Specialist for Abbott Diabetes Business (ADC) in Japan lead the process for ADC Japan in support of the organizations business objectives under the GVP Manager. The role is responsible for the quality assurance process for all Medical Device and IVD products for ADC Japan. The Sr. QA Specialist will ensure full compliance with all laws regulations policies and standards including PMD Act GVP Ordinance and relative Administrative addition compliance with Abbott SOPs and the development and implementation of additional local SOPs work instructions checklists etc. is required.

Responsibilities

• Manage Medical Device/IVD products safety process according to legal requirements and Abbott policies. Collaborate with Domestic Quality Assurance Manager in ADC Japan and other QA departments in Abbott Japan LLC.

• Establish and drive the safety strategy for ADC Japan by taking ownership and aligning with key Global Quality strategies and direction.

• Ensure consistent application of relevant Medical Device/IVD products safety processes and systems by clearly defining relevant Abbott and Abbott Diabetes Care SOPs and locally developed procedures. Adaptation of Global policies where required to execute activities appropriate to local requirements and market needs.

• Evaluate customer feedback including customer complaints and report to relevant competent authorities about Medical Device/IVD products Safety reports under local regulations.

• Elevate issues or significant events (Medical Device/IVD Products Safety issues) to the appropriate person with relevant facts and sufficient details to allow Subject Matter Experts responsible for the product safety quality and performance to analyze investigate and provide feedback and appropriate corrective actions.

• Close Medical Device/IVD products safety reports collaborating with Local/Area/Global Subject Matter Experts.

• Plan and execute Field Actions including Field Corrective Actions when necessary under close communication with Local/Area/Global Subject Matter Experts.

• Develop and maintain a Medical Device/IVD Products safety status report providing updates on key problem resolution initiatives.

• Escalate significant issues to Head of Quality and MAH Director about Medical Device/IVD products Safety process if applicable.

• Strong knowledge interpretation and understanding of the practice of Japan MHLW PMDA and Pharmaceutical Division of local government regulations building effective relationships with local regulators and agencies.

• Provide back up for QS QA and QC tasks as needed.

Background

• Medical device Pharmaceutical or related industry experience (5 years) in a QA/GVP/PV Role.

• Global cross-functional working experiences required.

• Strong knowledge of GVP Ordinance PMD Act. and relative Administrative Notifications related to Medical Device/IVD product Safety.

• Native in Japanese and ability to communicate fluently/effectively in spoken and written English is a must.

• Ability to develop resolution plans that take into account both project variables and potential intangible events so that success deadlines are routinely achieved.

• Strong knowledge of ISOCFR part820 and ISO14971 is preferable.

• QA experience in Medical Device is preferable.

• Desired skills/experiences include:

  • Familiarity with regulations such as ISO 9000/13485 QSR

  • Change management

  • Experience in working with matrix organizations

  • Program/project management

  • Cross-functional/cross-divisional experiences

  • Applicable technical knowledge/experience

  • Ability to develop procedures and policies that clearly define efficient and effective processes needed to ensure compliance and resolve identified problems.

  • Experience in leading and participating in cross-functional teams tasked with Medical Device/IVD product safety issues resolution

The base pay for this position is

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

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