Abbott QA Professional, Hematology in Santa Clara, California

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes, which adds value to the business.

Main Responsibilities

  • Analyze complaints and provide QA oversight in investigating potential non-conformances. Initial complaint investigations completed by a separate team

  • Provide quality assurance input into the analysis of potential product defects. Provide QA leadership in a cross-functional team to resolve product quality issues including CAPA

  • Participate in complaint tracking and trending activities. Utilize data from multiple internal sources (complaints, service tickets, parts usage, reliability) to proactively identify areas of opportunity for product enhancement and risk reduction

  • Participate and aid in product actions including field actions, service bulletins, customer communications and vigilance reporting

  • Conduct risk assessments and risk evaluations as part of the post-market surveillance and pre-market product development processes

  • Review and provide quality assurance approval for product documentation

  • Complete audit action item and CAPA effectiveness checks

  • Support inspections through direct involvement as a SME

  • Participate in business unit quality projects to improve procedures and process

  • Complies with regulations, company policies, operating procedures, and processes

  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Accountability/Scope

Receives general direction and exercises considerable discretion to own work detail.

Recommends possible solutions.

Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight.

Decisions may have short and long term impact.

Qualifications

Apprenticeship or Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience. At least 3 years’ work experience in Quality or related field experience; Less experience may be appropriate with advanced degree. Demonstrates understanding of how their function supports the business. Demonstrates technical and business competencies that drive results and continuous improvement.

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