Associate Compliance Engineer Job
Job Description Job Attributes+
Sylmar, CA, US
40 hours per week
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 115,000 colleagues serve people in more than 160 countries.
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
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
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.
This position works out of our Sylmar, CA location in the Cardiac Rhythm Management division.
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Associate Compliance Engineer generate's exception/CAPA documentation such as non- conformance reports and investigation reports required at the site for routine and non-routine manufacturing issues. Independently investigate all aspects of the exception event and determine the root cause, product impact, risk impact, corrections, and corrective/preventive actions. Utilize device design history files, specifications, test methods, factory data, field data, or quality policies as necessary to support decisions. Coordinate/facilitate meetings and/or communicate cross-functionally to develop solid solutions to CAPA activities. Work with Quality, Technical Operations, Manufacturing, Engineering, or purchasing as needed to recommend/document appropriate corrections, corrective/preventive actions based on facts obtained during base CAPA investigations. Concurrently manage multiple CAPA projects and tasks, ensuring timely completion. Track and trend CAPA related information, as appropriate, to meet compliance requirements. Be key contributor of CAPA team in identifying, developing, and implementing process or product improvements. Support the creation, implementation and modification of product and process related documents including Operating Procedures and other related documents.
What You’ll Work On
Ensure that all CAPA documents are written in compliance to Division policy and site procedures.
Document and investigate route and non-routine manufacturing issues independently or in collaborate with subject matter experts to develop robust CAPA solutions.
Concurrently manage multiple CAPA projects and tasks, ensuring timely completion.
Be key contributor to identifying and/or implementing CAPA process improvements.
Accountable for strict compliance to cGMP as it relates to CAPA documentation accuracy, decision accuracy, process compliance, process efficiency, and timeliness.
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelors Degree Related field. OR an equivalent combination of education and work experience
Minimum 2 years CAPA work experience in regulated, manufacturing environment
* 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 and @AbbottGlobal.
The base pay for this position is $53,700.00 – $107,300.00. In specific locations, the pay range may vary from the range posted.
- Manufacturing Environment
- Technical Operations
- Process Efficiency
- Preventive Actions
- Device Design
- Test Methods
Who We Are
PUT YOUR TALENTS TO WORK
Abbott values the leadership skills developed through military service and we have a broad range of functional areas to put your talents to work. Our organization is making a difference in the lives of the people we serve with a diverse offering of healthcare products. We have a strong veteran employee community to help with your transition from the military to the corporate world.