Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.
Abbott's life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.
The position of Manufacturing Line Quality Engineer is within our Infectious Disease Developed Markets business unit located at Westbrook, Maine. In this role you will provide support for product quality assurance, process improvements and all quality system program at the Westbrook Site.
WHAT YOU'LL DO
Support production with resolution of quality issues in accordance with established procedures.
Support production on the manufacturing floor, ensuring adherence to procedures and ensure appropriate device history record (DHR) documentation. Supports line clearances, reworks, and inspections as required.
Support the NC and CAPA processes by completing risk assessments, root cause investigations, and action plans.
Perform Risk Management activities using the Failure Mode and Effect Analysis methodology (e.g. dFMEA, pFMEA). Support peers in the development of mitigations for failure modes and verify the effectiveness of these mitigations.
Supports the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.
Reviews qualifications, validations, and other studies for technical content, statistical and sampling rationale, unintended impact and clarity. Act as the Quality representative for qualification and validation approvals for all validated equipment.
May participate on design transfer and improvement project teams.
Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
Other duties as assigned, according to the changing needs of the business.
EDUCATION AND EXPERIENCE YOU'LL BRING
2-5 years' experience in the medical device or other regulated industry.
Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) Certification
Knowledge of Agile program.
Working knowledge of Database software; Internet software; Inventory software; Spreadsheet software and Word Processing software.
Working knowledge of FDA, cGMPs/QSR and ISO quality system requirements
Strong technical writing skills and effective communication skills
WHAT WE OFFER
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
Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 and @AbbottGlobal.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.