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.

     

JOB DESCRIPTION:

About Abbott

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies 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.

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

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

THIS POSITION CAN ALSO BE BASED OUT OF OUR SITES LOCATED IN:

Columbus, OH

Chicago, IL

Westford, MA

WHAT YOU'LL DO

This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the division.

• Work with R&D and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.
• Create and execute or direct software validation protocols traceable to system/software requirements.
• Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.
• Assist in the completion and maintenance of risk analysis, focused on software related risks.
• Use laboratory test equipment and instrumentation to obtain test data from the devices and be capable of analyzing the data.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.
• Support internal (corporate and divisional) and external quality audits.
• 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.
• Develop and conduct training of company personnel for the divisional software development and validation program.
• 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.

Equipment:

Works with standard office equipment, telephone, cellular phone, and personal computer. Works with laboratory test equipment and instrumentation.

Working Conditions:

Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.

Physical Demands:

Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.

EDUCATION AND EXPERIENCE YOU'LL BRING

• BS degree in Engineering (e.g., Electrical, Computer science, etc.), or Technical Field or equivalent experience
• At least 7 years Software Quality Engineering experience.
• Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485
• Advanced computer skills, including statistical/data analysis and report writing skills
• Advanced Information Technology and data mining skills.
• Prior medical device experience preferred
• ASQ CSQE certification desired
• 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 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.
• Ability to travel approximately 5-10%.
• Ability to maintain regular and predictable attendance

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 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: www.abbottbenefits.com

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.

     

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.

JOB FAMILY:

Operations Quality

     

DIVISION:

AVD Vascular

        

LOCATION:

United States > Temecula : Building E - TE

     

ADDITIONAL LOCATIONS:

United States > Columbus : Columbus Plant, United States > Lake Forest : 840 S. Waukegan Road, United States > Massachusetts > Westford : 4 Robbins Road

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE:

Yes

     

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