Pleasanton, California

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 109,000 colleagues serve people in more than 160 countries.

Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in heart failure, allowing people to restore their health and get on with their lives.

**WHAT YOU’LL DO**

This position is responsible for supporting sustaining activities for the Operations Quality Engineering group.

+ Lead all activities for Non-Conformance Material Report’s (NCMR’).

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

+ Support CAPA Teams that are addressing manufacturing or design related issues.

+ Lead Test Method Validation (TMV) and Inspection Method Validation (IMV) activities.

+ Review and approve Process Failure Mode and Effects Analysis (pFMEA)Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ).

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

+ Develop Product Risk Assessment’s for patient safety for CAPA’s and other projects.

+ 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

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

+ Lead projects within the Operations Quality Engineering group

**EDUCATION AND EXPERIENCE YOU’LL BRING**

+ BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred

+ Minimum 7 years experience

+ Quality Engineering experience supporting sustaining production activities.

+ Solid communication and interpersonal skills

+ Project management and leadership skills

+ Computer skills, including statistical/data analysis and report writing skills

+ Prior medical device experience preferred

+ 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.

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

+ Multitasks, prioritizes and meets deadlines in timely manner.

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

**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 on-boarding 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: ** www.abbottbenefits.com (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

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 corpjat@abbott.com

Pleasanton, California

 

We’re dedicated to fulfilling the promise of human potential, in all places, in all aspects and stages of life. We believe that health is the key to that promise. Because at our healthiest, we’re capable of achieving anything. And that’s why our pursuit of helping people achieve their best health at every life stage will never end. This is how we put that belief into practice each and every day.

OUR PROMISE We are here for the people we serve in their pursuit of healthy lives. This has been the way of Abbott for more than a century—passionately and thoughtfully translating science into lasting contributions to health.

Our products encircle life, from newborns to aging adults, from nutrition and diagnostics through medical care and pharmaceutical therapy.

Caring is central to the work we do and defines our responsibility to those we serve.

  • We advance leading-edge science and technologies that hold the potential for significant improvements to health and to the practice of healthcare.
  • We value our diversity—that of our products, technologies, markets and people—and believe that diverse perspectives combined with shared goals inspire new ideas and better ways of addressing changing health needs.
  • We focus on exceptional performance—a hallmark of Abbott people worldwide—demanding of ourselves and each other because our work impacts people’s lives.
  • We strive to earn the trust of those we serve by committing to the highest standards of quality, excellence in personal relationships, and behavior characterized by honesty, fairness and integrity.
  • We sustain success—for our business and the people we serve—by staying true to key tenets upon which our company was founded over a century ago: innovative care and a desire to make a meaningful difference in all that we do.

The promise of our company is in the promise that our work holds for health and life.

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