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Abbott Quality Engineer in Westbrook, Maine

Position Summary:

Abbott Rapid Diagnostics (formally 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.

We are recruiting for a Quality Engineer to join our team within our Infectious Disease Developed Markets business unit located in Westbrook, ME. In this role you will provide support for contract manufacturing, product quality assurance, change management, process improvements, and quality system programs.

Primary Responsibilities:

  • Qualifications and Validations:

  • 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

  • Review and approve qualifications and validations of Non-Product Software (NPSW) verification/validation activities to ensure compliance with applicable QMS and regulations. Act as the Quality representative for Software Development Life Cycle (SDLC) processes with the cross functional team.

  • Nonconformance Investigation:

  • 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

  • Supplier Management Program:

  • Act as the Quality representative for day to day maintenance of supplier management documentation and processes

  • Support a contract manufactured product line

  • Change Control:

  • Act as the Quality representative for review, approval and implementation of change control records

  • 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

Required Qualifications:

  • Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field

  • 3+ years of quality experience in a regulated environment (i.e. medical device, aerospace, defense, pharmaceutical, etc.) including validation and CAPA investigations, change control justifications, and/or Quality Management System (QMS) experience.

  • Familiarity/working knowledge of Good Manufacturing Practices (GMP)

  • Proficient in MS Office (Word, Excel, Outlook)

  • Excellent verbal and written communication skills, with ability to communicate to all levels of the organization

Preferred Qualifications:

  • Advanced level degree in Biology, Chemistry, Life Sciences, or other related technical field

  • Previous medical device experience

  • Experience reviewing and approving non-product software validations

  • Technical writing skills

  • Working knowledge of FDA, QSR and ISO quality system requirements

  • Experience/exposure working in a Software Development Life Cycle (SLDC) environment

  • Certified Quality Auditor (CQA) Certification

  • Certified Quality Engineer (CQE) Certification

About Abbott:

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 accommodation, please send an email to MyRecruiter@alere.com.

Required Qualifications:

  • Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field

  • 3+ years of quality experience in a regulated environment (i.e. medical device, aerospace, defense, pharmaceutical, etc.) including validation and CAPA investigations, change control justifications, and/or Quality Management System (QMS) experience.

  • Familiarity/working knowledge of Good Manufacturing Practices (GMP)

  • Proficient in MS Office (Word, Excel, Outlook)

  • Excellent verbal and written communication skills, with ability to communicate to all levels of the organization

Preferred Qualifications:

  • Advanced level degree in Biology, Chemistry, Life Sciences, or other related technical field

  • Previous medical device experience

  • Experience reviewing and approving non-product software validations

  • Technical writing skills

  • Working knowledge of FDA, QSR and ISO quality system requirements

  • Experience/exposure working in a Software Development Life Cycle (SLDC) environment

  • Certified Quality Auditor (CQA) Certification

  • Certified Quality Engineer (CQE) Certification

About Abbott:

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 accommodation, please send an email to MyRecruiter@alere.com.

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

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