Senior QMS & Compliance Specialist
Abbott
Summary
Education: Associates Degree (± 13 years)
Job description
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: Minimum 4 years in the related field.
Requirements
- Associates Degree
- Minimum 4 years in the related field
- Leads/supervises a team of 2 or more professionals
- Mentoring, coaching, and coordination
Benefits
- Medical coverage
- Retirement savings plan
- Tuition reimbursement
- Student debt program
- Education benefit
Company overview
Abbott Laboratories is a global healthcare leader with a 135-year legacy of innovation, dedicated to helping people live healthier, fuller lives through life-changing technologies and products. Headquartered in Abbott Park, Illinois, the company operates in more than 160 countries with a workforce of approximately 114,000 professionals. Abbott's diversified portfolio spans four core business segments: medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals. The company is particularly renowned for its groundbreaking medical devices including cardiovascular technologies, diabetes management systems like the FreeStyle Libre continuous glucose monitor, neuromodulation devices for chronic pain, and the AVEIR DR dual chamber leadless pacemaker system. In diagnostics, Abbott has been instrumental in developing critical tests, including the first licensed HIV test in 1985 that helped secure blood supply safety. The company's nutrition division produces leading infant formulas like Similac, while its pharmaceutical business provides quality branded generic medicines. Abbott consistently ranks among Fortune's Most Admired Companies and maintains a strong commitment to sustainability and corporate responsibility, making it a trusted partner in advancing global healthcare.