At Abbott, diverse ideas, perspectives, and expertise allow us to create life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
We have an exciting opportunity for a Quality Engineer within our Abbott Rapid Diagnostics business located at Scarborough, Maine. In this role, you will provide support for product quality assurance, process improvements and all quality system program at the Scarborough Site.
Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
Review 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.
Coordination of the Scarborough Material Review Board (MRB): Develop and maintain processes for managing nonconforming materials and processes, including linking these events to lot history records and material transactions.
Act as the Quality representative in the review and disposition of non-conformances, assuring appropriate decisions, testing, data and records are completed.
Act as a technical resource to assure customer-centric resolution to non-conformances.
Act as the Quality representative for day to day maintenance of supplier management documentation and processes.
Act as the Quality representative for review and approval of reports and documents associated with design changes and may also act as Project Manager for Design Changes.
Develop and support the Quality Assurance training programs.
Develop test and inspection plans.
Review and assess from a technical perspective the content of all manufacturing, process, procedure and material changes. Assist in process data collection and analysis, provide training in the use of statistical techniques as needed.
Support the internal audit program, assuring its technical content and compliance to applicable standards.
Participate in 1st party (internal) and 2nd Party (External) audits and track audit findings to completion.
Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field or the equivalent combination of education and experience.
3+ years’ experience in the medical device industry or regulatory function.
Certified Quality Auditor (CQA) Certification
Knowledge of ensur and Agile programs.
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
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.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to email@example.com.
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 103,000 colleagues serve people in more than 160 countries.