Abbott Sr Sterility Assurance Engineer in Abbott Park, Illinois
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.
This Sr Sterility Assurance Engineer position is focused on supporting a new manufacturing line in the Chicago area for our FreeStyle Libre product (recently PMA approved). This is an individual contributor with comprehensive knowledge in the specific area. Ability to execute highly complex or specialized projects. Adapts precedent and may make significant departures from traditional approaches to develop solutions. Responsible for designing and maintaining programs for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. Has appropriate knowledge of appropriate regulations and/or standards related to sterilization.
Under general direction, has duties of instructing, directing, and checking the work of other quality assurance professionals.
Responsible for application of quality principles and complex analysis of quality records, reports to form recommndations for improvements.
Conduct inspection, verification and validation of components or materials used in development processes.
Identify and address recurring problems either with the quality of the product or the reliability of testing procedures.
Document quality issues and performance measures for management review.
May liaise with external vendors.
Bachelors Degree, scientific discipline preferred or an equivalent combination of education and work experience. Minimum 6 years Quality Assurance experience in the medical device, pharmaceutical or other quality managed industries. Working knowledge of applicable regulations such as FDA, QSR, ISO, MDD, or IVDD. Knowledge in the areas of design controls, process validation, manufacturing practices and statistical techniques
Experience with E-beam or Gamma sterilization validations following ISO11137
Working knowledge of cleanroom practices and environmental monitoring processes following ISO14644
Excellent knowledge of FDA Quality System Requirements and ISO13485.
Graduate degree in Microbiology or equivalent scientific discipline.
Ideal candidate would have experience in an automated medical device manufacturing environment.
Ability to maintain and generate accurate records with excellent attention to detail
Strong written, verbal communication skills
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 firstname.lastname@example.org