Abbott Hiring for Software Quality Engineer at Lake Forest, IL, United States Full Time

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 115,000 colleagues serve people in more than 160 countries.

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.

Youll 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 (https : / / www.abbott.com / corpnewsroom / strategy-and-strength / tackling-student-debt-for-our-employees.

html) student debt program and FreeU (https : / / www.abbott.com / corpnewsroom / strategy-and-strength / college-degree-for-free-its-possible-with-freeu.

html) education benefit – an affordable and convenient path to getting a bachelors 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 role is based in the Lake Forest, IL Abbott Office. If hired, you will support one of our Global Quality Engineering teams in software product development, manufacturing including engineering design review, verification / validation activities.

What Youll Work On

• Defines design document requirements for Design Control and Software Development Life Cycle (SDLC). Reviews and approves software lifecycle deliverables.
• Directly influences project direction and scope, guides product development teams and assures robust product vs. customer requirements.
• Supports Risk Management activities. Assesses internal and external risks associated with specific actions, quantifies risks, seeks input from others, and identifies actions to limit the exposure of the division.
• Applies established quality and engineering methods to the investigation and solution of software quality problems.
• Performs CAPA (Corrective Action Preventive Action) and FCA (Field Corrective Action).
• Determine the impact of a change on the safety and efficacy of a software product, device, process performance, and internal / external customer expectations worldwide.
• Support supplier qualification and maintenance activities. Performs SCAR (Supplier Corrective Action), and process deviation activities.
• Participate and support internal audits, non-product software lifecycle activities, multi-site and business wide software lifecycle activities.
• Interface with product team members, manufacturing quality and medical affairs.

Required Qualifications :

Bachelor’s Degree ( 16 years) in a science, statistics, engineering discipline or ASQ Quality Engineering certification.

Or an equivalent combination of education and work experience.

Minimum 5 years Related work experience in similar area.

Preferred Qualifications :

• Bachelor’s Degree in a Software discipline preferred or 4-5 years of Software Quality experience.
• 1-2 years in a regulated environment, preferably in medical devices with excellent understating and knowledge of quality system processes.
• Understand quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, IEC62304, IVDD).
• Experience in reviewing, and executing validation and change control documents, authoring SOPs, Protocols.

Competencies :

• Flexibility to adapt to changing assignments and ability to effectively prioritize.
• Capable of analyzing data to support the development of strategies to effectively manage, enhance, mitigate, and / or resolve potential issues.
• Demonstrate accountability for complying with local and global Quality System requirements.
• Provide consultation in quality, compliance, and technical areas across multiple work groups.
• Provide constructive and timely feedback to ensure compliance and mitigate risk.
• 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 (http : / / www.abbottbenefits.com / pages / candidate.aspx)

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 and @AbbottGlobal.

The base pay for this position is $62,700.00 $125,300.00. In specific locations, the pay range may vary from the range posted.

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 [email protected]