Senior QMS & Compliance Specialist

Abbott; Los Angeles (CA); Sur place; USD 90 000 - 180 000; Plein temps

Avantages offerts par ce poste

Health coverage

Retirement plan

Tuition reimbursement

Education benefits

Résumé du poste

Abbott is seeking an onsite Quality Assurance role in Sylmar, CA. The person will lead a team and focus on mentoring, coaching, and coordinating activities within a regulatory environment.

The role requires maintaining documentation systems, ensuring compliance with regulatory agencies, and managing records and dossiers for product information. A strong background in regulatory documentation is essential.

Qualifications

• Associates Degree required.
• Minimum 4 years in the related field.

Responsabilités

• Maintains a controlled documentation system and records retention per regulatory requirements.
• Ensures compliance with regulatory agency requirements.
• Maintains the documentation change system for technical and non-technical documents.
• Implements procedures to classify and maintain records.
• Interprets and enforces documentation formatting, standards, policies, and SOPs.
• Coordinates assembly of regulatory dossiers and communicates documentation standards.

Connaissances

Mentoring

Coaching

Record keeping

Formation

Associates Degree

Outils

Regulatory documentation systems

Description du poste

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 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 Details Minimum 4 years in the related field.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

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)

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.

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.

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

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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