Senior Design Quality Engineer

Senior Design Quality Engineer

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.

The Opportunity

This position works out of our Dallas, TX location in the Core Lab Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

As the Senior Design Quality Engineer, you’ll be responsible for developing and maintaining quality engineering methodologies in pursuit of delivering products that are safe and effective, meet patient and user needs, apply appropriate human factors engineering, and are compliant to all pertinent regulatory requirements by providing quality engineering support within new product development, manufacturing, or system/services support.

What You’ll Work On

• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.

• Lead, coach, and mentor non-exempt and entry level exempt personnel

• Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Appropriately document experiment plans and results, including protocol writing and reports.

• Lead process control and monitoring of CTQ parameters and specifications.

• Support the development, implement various product, and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

• Support the investigation, resolution and prevention of product and process nonconformances.

• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)

• Participate in or lead teams in the completion and maintenance of risk analysis.

• Work with design engineering in the completion of product verification and validation

• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS).

• Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications

• Bachelors Degree Engineering or Technical Field; OR an equivalent combination of education and work experience.

• Minimum 5 years experience.

Preferred Qualifications

• Engineering experience and demonstrated use of Quality tools/methodologies.

• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.

• Advanced computer skills, including statistical/data analysis and report writing skills.

• Prior medical device experience preferred.

• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).

• Experience working in a broader enterprise/cross-division business unit model preferred.

• Ability to work in a highly matrixed and geographically diverse business environment.

• 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 timely manner.

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

• Ability to maintain regular and predictable attendance.

* 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 and @AbbottGlobal.