Quality System Analyst I - Medical Devices (On-Site)

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.

• 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.

For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring system, 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.

The Opportunity

Our location in Sylmar, CA currently has an opportunity on-site for a Quality Systems Analyst I. This position is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System.

What You'll Work On

• Responsible for implementing and maintaining the effectiveness of the Quality System.

• Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.

• Assist in determining quality attributes and requirements. may provide technical assistance.

• Utilize quality management techniques to perform investigations and facilitate solutions.

• Responsible for completing documentation in a timely manner and in accordance with business standards.

• Participate on cross-functional teams.

• Other tasks and duties as assigned.

• Understand and comply with applicable EHS policies, procedures and guidelines.

• Works under the supervision of more experienced staff who review results for overall accuracy, completeness and sound judgment.

• Recognizes risks versus the relative gains associated with actions; understands a project's critical success factors and makes recommendations and decisions impacting those factors.

• Responsible to meet established objectives and goals.

• Drives functional performance to ensure that cross-functional standards and expectations are met.

• May assist in the training of personnel as directed by management.

Required Qualifications

• Bachelor's Degree OR an equivalent combination of education or work experience.

• Entry level position in which 0-2 years of experience is typical to meet the skills and responsibilities of the position.

• Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices.

• Knowledge of ISO 13485 standard.

• Knowledge of quality management techniques and application.

• Ability to clearly, concisely and accurately convey written and oral communications.

• Ability to form and develop interpersonal, professional relationships.

• Display socially and professionally appropriate behavior.

• Ability to work independently and in groups as well as work cross-functionally across teams.

• Demonstrated initiative, critical-thinking and problem-solving skills.

• Ability or aptitude to use various types of databases and other computer software.

• Strong organizational skills.

• Ability to prioritize and multitask.

• Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.

• Ability to quickly gain knowledge, understanding or skills and is willing to learn.

Preferred Qualifications

• Bachelor's degree.

• Prior medical device experience

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

• Prior audit experience.

Apply Now

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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 $55,200.00 - $110,400.00. In specific locations, the pay range may vary from the range posted.