Senior QMS & Compliance Specialist

Abbott • Sylmar, MD

3d • $90,000 - $180,000 • Onsite

About The Position

This onsite role is based in Sylmar, California, within Abbott’s Cardiac Rhythm Management division. The position leads and supervises a team of two or more professionals and serves as a first-level manager of a work team that may include professional, technical, or administrative staff. The role typically has no budget or hiring/firing authority and focuses on mentoring, coaching, and coordination.

The position is responsible for controlled documentation and records processes, including electronic records retention, regulatory compliance, documentation change control, records classification and maintenance, and enforcement of documentation standards and procedures. It may also support regulatory dossier assembly, prepare information abstracts and executive summaries, and maintain product knowledge and customer contacts.

The role requires at least four years of experience in the related field and an associate degree. Travel is listed as 5% of the time. The base pay range is $90,000 to $180,000.

Requirements

• Associate degree.
• Minimum of 4 years of experience in the related field.

Responsibilities

• Ensure a controlled documentation system, record retention, and information services—including electronic records retention processes—in accordance with regulatory requirements.
• Ensure compliance with requirements from regulatory agencies.
• Maintain the technical and non-technical documentation change system.
• Ensure procedures are in place to classify and maintain records.
• Interpret and enforce 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, and 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.
• Lead and supervise a team of two or more professionals, focusing on mentoring, coaching, and coordination.

Benefits

• Free medical coverage for employees via the Health Investment Plan (HIP) PPO, subject to the stated wellness assessment qualification.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit for pursuing a bachelor’s degree.
• Career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree