Quality Engineer

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.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

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.

Our location in Westford, MA, currently has an opportunity for a Design Quality Engineer.

The Opportunity

This position works out of our Westford, MA, location in the Abbott Vascular Division. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?ngersticks. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

What You'll Work On

A Design Assurance Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

MAIN RESPONSIBILITIES

• Execute and support on-time completion of Design Control Deliverables.

• Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.

• Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities.

• Lead or support Risk Management activities from product Concept through Commercialization.

• Support design test and inspection method development, and lead method validation activities.

• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.

• Support manufacturing process development & qualification for new product commercialization and product changes.

• Support internal & external audit responses.

• Support product re-certifications.

• Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements.

• Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications.

• Support execution of biocompatibility and sterilization qualifications.

• Complete Document Change Request Reviews in a timely and objective manner.

• Additional duties may be identified by functional management based on the current project/business objectives.

• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

EDUCATION AND EXPERIENCE YOU'LL BRING

Minimum Education/Experience Required

Bachelor's degree and 2-5+ years experience in a science, statistics, engineering discipline or ASQ Quality Engineering certification OR Sufficient practical experience to demonstrate functional equivalence.

Minimum Experience / Training Required

Bachelor's degree in a science, statistics, engineering discipline or ASQ Quality Engineering certification OR Sufficient practical experience to demonstrate functional equivalence.

Apply Now (~~~)

• 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: ~~~ (~~~)

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 ~~~ , on Facebook at ~~~/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $57,300.00 - $114,700.00. 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 ~~~ or email ~~~