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 114,000 colleagues serve people in more than 160 countries.

Quality Engineer Manager

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

Career development with an international company where you can grow the career you dream of.

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with high employer contribution

Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Westbrook, Maine location in Abbott Rapid Diagnostics Scarborough, Inc.. Abbott Rapid Diagnostics is part of Abbott’s Rapid and Molecular 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 Quality Engineer Manager is within our Infectious Disease Business Unit located at all sites under Abbott Diagnostics Scarborough QMS. This role will provide support for product quality assurance, equipment/process validation, continual improvement, and other quality system programs.

What You’ll Work On

Responsible for managing, training, and supporting the work of the Quality Engineer team in their designated responsibilities.

Responsible for audit readiness support and for data generation for periodic management or Change Review Board meetings.

Responsible for participating in as well as overseeing and coordinating management of designated quality engineer reports, in the following reviewing qualifications, validations, and other studies for technical content, statistical and sampling rationale, unintended impact and clarity.

Acting as the quality representative for qualification and validation approvals for all validated equipment.

Reviewing and assess from a technical perspective the content of all manufacturing, process, procedure, and material changes.

Assisting in process data collection and analysis, provide training in the use of statistical techniques as needed.

Participating in the Material Review Board (MRB)

Acting as the quality representative in the review and disposition of non-conformances, assuring appropriate decisions, testing, data, and records are completed.

Acting as a technical resource to assure customer-centric resolution to non-conformances.

Facilitate Validation Review Board

Act as the quality representative for review and approval of reports and documents associated with change management and may also act as project manager for change management activities. Supports development to risk assessments around the changes.

Acting as the quality representative in the review and approval of Risk Management Files and providing input into the Risk Management Process.

Developing and supporting the quality assurance training programs as needed.

Supporting the development of test and inspection plans.

This position may lead or participate in site projects or corporate projects.

Providing support to the operations group, as necessary.

Supervisory Responsibilities

This job has supervisory responsibilities of the Manufacturing LineQE Supervisors and Validation QE individual contributors. This individual shall carry out their supervisory responsibilities in accordance with the organization’s policies and applicable laws.

Other responsibilities include participating in interviews; providing input on appraising performance; providing input on rewarding and disciplining employees; addressing complaints and resolving problems.

Required Qualifications

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

10+ years’ experience quality and/or regulatory roles in regulated industry (i.e., Medical Diagnostics, Medical Device, Pharmaceutical, etc.).

Working knowledge of database software; Internet software; Inventory software; Spreadsheet software, Word Processing software and statistical software.

Working knowledge of FDA, cGMPs/QSR and ISO quality system requirements.

Strong technical writing skills and effective communication skills.

Preferred Qualifications

Experience with Lean / Six Sigma

Experience working in a broader enterprise/cross-division model.

Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

Ability to leverage, and/or engage others to accomplish projects.

Multitasks, prioritizes, and meets deadlines in a timely manner.

Strong organizational and follow-up skills, as well as attention to detail.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.

The base pay for this position is $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.