Job Description:

Abbott Rapid Diagnostics is part of Abbotts 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.

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.

This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:

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 companys 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.

BASIC QUALIFICATIONS | EDUCATION:

Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field or the equivalent combination of education and experience.

PREFERRED QUALIFICATIONS:

Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) Certification

COMPETENCIES:

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

Alere, Inc.(Now Abbott) is an equal employment/affirmative action employer of Minorities/Females/Protected Veterans/Disabled. If you need accommodation for any part of the employment process because of a disability please send an email to jobs@alere.com to let us know the nature of your request

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