Specialist Quality Assurance

Specialist Quality Assurance

Working at Abbott

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

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

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• An excellent retirement savings plan with a high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The primary function of the Quality Specialist is to assist in maintaining the quality system.

The role can have responsibility for one or more of the following processes:

• Batch release

• Complaint Coordination

• Metric maintenance

• Surveillance Program

• Testing Program

• Document Control

• Exception Report and CAPA System

• Batch and Sample Retention and Maintenance

This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday.

What You’ll Work On

• 
  Assist with administration and ensuring compliance to Quality Management Systems including:

• Complaints Coordination, Batch Release, Exception Reports, CAPA, Document Control, Surveillance, Testing, Batch and Sample Retention and Maintenance, Metric etc.

• Actively monitors Third Party Manufacturers data and Support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory (cGMP, ISO) regulations.

• Reviews GMP related documentation for compliance such as batch records and associated data related to product manufacturing, testing and release, validation protocols and reports, labels, product specifications and other documentation as required.

• Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations in the Manufacturing area as required.

• Maintains product complaint logs to identify and report recurring issues to quality assurance management and product development. Collaborate with other internal groups to respond to product inquiries and issues.

• Writes and revises SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.

• Collaborates with members of the Quality Assurance team working on special projects.

• Participate on permanent and temporary teams which are process or project driven.

• Become familiar and subject matter expert on electronic support systems, TraqWise, GQMS, TeamCenter, compliance wire etc.

• Collect analysis and publish quality metrics.

• Provide data for support of budgetary submissions.

• Assist with other support duties as assigned.

Required Qualifications

• Bachelors Degree with a minimum of 2 yrs of experience or equivalent education and work experience will be accepted.

• Prior experience in the medical device industry and/ or quality systems are required.

Preferred Qualifications

• Strong working knowledge of FDA Code of Federal Regulations as it applies to medical device manufacturing, including cGMP, ISO14971, as well as complaint handling systems a huge plus.

• Related work experience in customer complaints and product nonconformances strongly preferred.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

Divisional Information

Medical Devices