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Job Description

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.

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. 

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.  

Our location in Temecula, CA currently has an opportunity for a Sr. Quality Engineer.

THIS IS AN ON-SITE DAILY POSITION.

OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL BASED ON EXPERIENCE.

WHAT YOU’LL DO

This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

Core Job Responsibilities:

• Performs assignments of a very complicated or difficult nature requiring a high degree of technical competence.
• Lead on-time completion of Design Control Deliverables
• 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 and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
• Support manufacturing process development & qualification for new product commercialization and product changes
• Support/ Lead  and ensure internal & external audit responses
• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
• 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
• Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
• Lead 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)
• Lead Risk Management activities from product Concept through Commercialization 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. Performs other related duties and responsibilities, on occasion, as assigned.

EDUCATION AND EXPERIENCE YOU’LL BRING

Minimum Education:

Bachelor’s degree AND 6+ years of related work experience with a basic understanding of specified functional area, or an equivalent combination of education and work experience.

Minimum Experience / Training Required:

• Demonstrated supervisory experience preferred.
• Engineering experience and demonstrated use of Quality tools/methodologies.
• 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.
• 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).

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority
• Production areas that are clean, well-lit and temperature-controlled
• Training and career development, with onboarding 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: 

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 , on Facebook at on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.