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.

JOB DESCRIPTION:

Working at Abbott:

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements.

What You’ll Work On

• Contributes to the development, maintenance and improvement of division supplier development quality program policies, procedures and forms.

• Owner of Non-Conforming Material Reports (NCMRs) issued to supplier for nonconforming supplied material and works with the supplier on the investigation and root cause analysis. May provide coaching and mentoring for technical team personnel.

• Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements.

• Reviews and approves all supplied product drawings and component quality plans.

• Manages development of supplied product inspection procedures and first article requirements.

• Notifies suppliers of customer complaints related to failures resulting from supplied material and requires investigation and corrective action.

• Leads projects with a cross-functional team for supplier requested changes or improvements.

• Provides engineering guidance to division Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.

• Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits

• Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products.

• Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions.

• Contributes and participates in supplier performance reviews.

• Works with Manufacturing Engineering to assess and address purchased product issues.

• Design and conduct experiments for process optimization and/or improvement

• Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member)

• 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.

Required Qualifications

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

• Minimum 5 years of related experience.

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

• Solid communication and interpersonal skills.

• 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.

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

• Ability to travel approximately 10-20%, including internationally.

Preferred Qualifications

• Advanced degree.

• Prior medical device experience.

• Demonstrated supervisory experience.

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

• Advanced computer skills, including statistical/data analysis and report writing skills. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). ASQ CQE or other certifications.

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

Apply Now 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 @Abbott News.

The base pay for this position is

$90,000.00 – $180,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

HF Heart Failure:

LOCATION:

United States > Pleasanton : 5000 Franklin Dr

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 15 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

• EEO is the Law link

• English: http://webstorage.abbott.com/common/External/EEO_English.pdf

• EEO is the Law link

• Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf