Senior QMS & Compliance Specialist

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.

About Abbott

• 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.
• 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.
• 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.

Responsibilities

• Focuses on mentoring, coaching, and coordination.
• 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.

Requirements

• 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.
• Education Associates Degree ( ± 13 years) Experience/ Background Experience Experience Details Minimum 4 years in the related field.

Pay

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.

Benefits

• 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.
• 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.

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