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Abbott Commercial Quality Specialist APAC in Mumbai, India

Company Name: Abbott Point of Care

Position Location: Mumbai, India

Position Title: Commercial Quality Specialist APAC

Company Summary/ Position Description:

Abbott: Making An Everlasting Impact on Human Health for 125 Years

Abbott is a global health care company devoted to improving life through the development of products and technologies that span the breadth of health care. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 99,000 people. In 2018, the company's sales exceeded US$30.6 billion.

Abbott Point of Care: Poised for Growth

Abbott Point of Care (APOC), a $600 million division of Abbott (NYSE: ABT), enables health care professionals to accurately achieve real-time, lab-quality diagnostic results at the point of care within minutes. Testing at the point of care enables health care professionals to make rapid triage and treatment decisions when diagnosing a patient’s condition or monitoring a treatment response. By simplifying the testing process, clinicians can focus on what matters most—caring for the patient.

Abbott Point of Care’s i-STAT Analyzer is a handheld system that is used with single-use i-STAT test cartridges. Together they form the i-STAT System*—a blood analysis system that provides health care professionals with the information they need to rapidly make treatment decisions. Patient bedside testing with the i-STAT System is as easy as inserting two or three drops of blood into the cartridge, inserting the cartridge into the handheld, and then viewing test results in as little as two minutes for most cartridges. Test results are uploaded automatically—delivered wirelessly with the i-STAT Wireless or directly when the i-STAT handheld is placed in a downloader. The i-STAT System eliminates process steps and handoffs to help reduce the incidence of errors and promote patient safety.

Hospitals and clinics in more than 100 countries around the world depend on the i-STAT System in critical care situations. For more information about Abbott Point of Care and the i-STAT System, please visit https://www.pointofcare.abbott.

Commercial Quality Specialist APAC:

  • Support Commercial Quality System management maintenance in APAC region

  • This is an individual contributor and report to Quality Compliance Manager APAC

Attractive Features of Company and This Position

At Abbott, you can have a good job that can grow into a great career. We offer:

  • Training and career development , with onboarding programs for new employees and tuition assistance

  • Financial security through competitive compensation, incentives and retirement plans

  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

  • Paid time off

  • 401(k) retirement savings with a generous company match

  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Responsibilities:

  • Distributor Management

  • Perform audit and approval of distributors as part of the distributor selection, qualification, and approval process. This includes audit scheduling and execution, audit report preparation and the follow-up of distributor corrective actions.

  • Prepare, co-ordinate the sign-off for distributor Quality Agreement to ensure robust partnerships exist.

  • Communicate and train distributors on APOC quality requirements.

  • Maintain Approved Distributor List and performance profile, including change control, report card issuance etc.

  • Quality Management System Maintenance

  • Support CAPA management and follow up action per assignment.

  • Support Management Review process including material preparation and document filing.

  • Support internal & external audits

  • Support supplier management per needs including audit, performance monitoring, etc.

  • Keep vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.

  • Work closely with relevant Divisional functions and local cross functional team to support business needs.

  • Perform other duties & projects as assigned.

Qualifications/ Experience:

  • A minimum of 3 years of QA experience in Medical Device or Pharmaceutical industries

  • Experience in cold chain product management, CAPA/NC management, Audits, warehouse management are preferred.

  • In-depth knowledge of international quality systems and medical device standards, such as ISO 13485, ISO 9001, MDSAP, etc.

  • Excellent verbal communication skills appropriate for acting as a liaison between APOC and its distributors/suppliers.

  • Ability to work independently and in groups; ability to work cross-functionally; ability or aptitude to exercise judgment within defined procedures and practices to determine appropriate action.

  • Ability to work independently with minimal supervision. Ability to work and interact with multiple cultures in different time zones.

  • Be proficient in use of personal computer and business/technical software (e.g., Microsoft Office).

Qualifications

  • Apprenticeship or Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.

  • ASQ Certification (CQA, CQE) or equivalent; specific work experience in quality auditing may be substituted for certificate.

Mobility: 15% travel

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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