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.

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

Sr. Quality Assurance Engineer

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.

Quality Assurance Engineer will be responsible for leading projects and serving as a domain expert  in the implementation of the Quality Management System, in accordance with corporate, divisional and applicable regulatory requirements.

MAIN RESPONSIBILITIES

• Plan, Coordinate, and Execute on QMS related initiatives including procedures, tooling, and improvement initiatives.

• Prioritize and co-ordinate project efforts to ensure department and Lingo goals are achieved.

• Support other Quality Engineering activities, including, but not limited to new product development, review and approval of product changes, supplier management, and software validation.

• Manage the investigation of non-conformances affecting area of responsibility, and ensure implementation of timely and effective corrective action, as needed.

• Provide effective project leadership on projects you lead/manage by ensuring stakeholder alignment and management buy-in.

• Maintain an appropriate balance of quality, compliance and business risk. Provide compliant yet practical solutions that minimize the impact of Quality issues.

• Implement communications, interpersonal interactions and business behaviors which are consistent with Lingo values and the Abbott Code of Conduct.

• Build and maintain effective cross functional relationships with all areas of the business.

• Present and communicate status, report metrics, identify trends and potential issues and escalate to management any issues pertaining to projects, non-compliance, or other targets/goals.

• Ensure area of responsibility and processes are audit ready at all times and all audits are supported from a resource and information request perspective.

• Maintain the quality and compliance status of associated procedures, work instructions and training materials.

• Identify and implement initiatives for continuous improvement of the Quality System.

• Ensure approaches to Quality and Compliance are consistently applied within the business and across the Division.

• Provide divisional level support and guidance as SME for area of responsibility.

• Liaise with functional leadership concerning the allocation of project resources.

• When requested, accept any responsibilities and perform any necessary tasks to support the business and other QA activities.

• Proactively address Health and Safety concerns within the working environment in order to reduce hazards and risk.

QUALIFICATIONS

Education

Bachelors Degree

• In a computer science, Information Technology, biology, engineering or other relevant field or an equivalent combination of education and work experience

Experience/Background

• 5-8 years of working in a Quality and/or Regulatory role in a regulated industry (e.g., Healthcare, biotechnology) with experience in managing projects from start to finish,
• First-hand knowledge of FDA QSR 21 CFR Part 820, relevant ISO standards such as ISO 13485, ISO 14971, and 21 CFR Part 11,
• Prior experience in configuring, validating, and/ launching internal (nonproduct) software is preferred,
• Quality or Regulatory professional certification a plus.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.