Senior QMS & Compliance Specialist

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 122,000 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.
• 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.

MAIN PURPOSE OF THE ROLE

• This is an ONSITE role based out of Sylmar, CA
• Leads/supervises a team of 2 or more professionals.
• First level manager of a work team that could comprise professionals, technical and/or administrative staff.
• Typically without budget or hire/fire authority.
• Focuses on mentoring, coaching, and coordination.

MAIN RESPONSIBILITIES

• Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
• Ensures compliance to the requirements from regulatory agencies.
• Maintains the technical and non-technical documentation change system.
• Assures procedures are in place to classify and maintain records.
• Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements.
• May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers.
• May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched.
• May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.

QUALIFICATIONS

Education

• Associates Degree (± 13 years)

 Experience/ Background

Experience

• Experience Details
• Minimum 4 years in the related field.

 

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 and @AbbottGlobal.

     

The base pay for this position is

$90,000.00 – $180,000.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Quality Assurance

     

DIVISION:

CRM Cardiac Rhythm Management

        

LOCATION:

United States > Sylmar : 15900 Valley View Court

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

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