• Job Description

  Req#: 31118872
  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.
  JOB DESCRIPTION:
  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 Deliverables
  • Create and ensure 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 Risk Management activities from product Concept through Commercialization
  • Lead 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
  What You’ll Work On
  • Support/lead and ensure internal & external audit responses
  • Support/lead and ensure on time product re-certifications
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Accountable for development, execution and analysis of biocompatibility and sterilization qualifications
  • Complete Document Change Request Reviews in a timely and objective manner
  • Develop 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 experience
  • Minimum 5 years Previous Quality engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, and ISO 13485
  • Solid 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 Preferred
  • Prior 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.
  JOB FAMILY:
  Operations Quality
  DIVISION:
  AVD Vascular
  LOCATION:
  United States > Temecula : Building E - TE
  ADDITIONAL LOCATIONS:
  WORK SHIFT:
  1St Shift Clip Line (United States Of America)
  TRAVEL:
  Yes, 10 % of the Time
  MEDICAL SURVEILLANCE:
  No
  SIGNIFICANT WORK ACTIVITIES:
  Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
  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

• About the company

  Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, United States.

Notice