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.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 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
 

The Sr, Quality Engineer position works onsite of our Temecula, CA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

Lead on-time completion of Design Control DeliverablesCreate and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projectsAccountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activitiesLead Risk Management activities from product Concept through CommercializationLead design test and inspection method development, and lead method validation activitiesEnsure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gapsSupport manufacturing process development & qualification for new product commercialization and product changes

What You’ll Work On

Support/lead and ensure internal & external audit responsesSupport/lead and ensure on time product re-certificationsSupport and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirementsSupport and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualificationsAccountable for development, execution and analysis of biocompatibility and sterilization qualificationsComplete Document Change Request Reviews in a timely and objective mannerDevelop and lead other team members.Perform other duties and responsibilities as assigned by management.Support/lead 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.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 ☒ an equivalent combination of education and work experienceMinimum 5 years Previous Quality engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, and ISO 13485Solid communication and interpersonal skills. 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.

​Preferred Qualifications

Masters Degree PreferredPrior medical device experience preferred. ASQ CQE certification preferred. Design for Six Sigma and Critical to Quality training and experience preferred. 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 Ability to travel approximately 10%, including internationally.

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 @AbbottNews.

The base pay for this position is $75,300.00 – $150,700.00. In specific locations, the pay range may vary from the range posted.