Senior Quality Engineer, Design Quality - Lifecycle Management

AbbVie

Confirmed live 2 days ago High trust
Hybrid

Quick summary

Work type
Hybrid
Location
North Chicago, IL
Salary
$84,500–$162,000 / yr
Posted
18 days ago
Freshness
Confirmed live 2 days ago
Closes
Aug 24, 2126

Market check

Salary context

Below market

How this pay compares to similar roles

Similar $161k
This role $123k
$71k most similar roles pay here $207k

This role pays less than 89% of similar roles. Most pay $134,050–$187,062 — the shaded band above. At the midpoint, this role pays about $123k versus about $161k for comparable roles.

Based on 240 similar postings.

Employer

About AbbVie

AbbVie is a global biopharmaceutical company focused on discovering and delivering innovative medicines and solutions in immunology, oncology, neuroscience, and eye care. Its products include Humira, Skyrizi, and Rinvoq.

AbbVie currently has 297 open roles on FindRole.

Listed pay typically runs $109,500–$208,500 across 271 roles with salary data.

Most-posted roles

View all roles at AbbVie

At a glance

TL;DR · Senior Quality Engineer, Design Quality - Lifecycle Management

Senior Quality Engineer- Design Quality – Lifecycle Management serves as a primary quality lead for cross-functional teams to manage design transfer and change management for medical devices and combination products. The role involves executing Quality System requirements to ensure products move from development to manufacturing while maintaining compliance with local and global regulations. Key responsibilities include performing risk management, maintaining Design History File documentation, managing third-party suppliers, and supporting equipment qualifications like IQ/OQ/PQ. Candidates must possess a technical degree and experience with 21 CFR 820, EU MDR 2017/745, ISO 13485, and ISO 14971. The position focuses on the lifecycle of products such as infusion pumps, autoinjectors, and aesthetic devices, ensuring that all design control activities and change impact assessments meet rigorous regulatory standards and internal quality policies throughout the product's market presence.

What you'll do

  • Execute design control and risk management activities for medical devices and combination products.
  • Manage Design History File (DHF) documentation and ensure compliance with quality system requirements.
  • Lead design transfer activities to facilitate product launches both internally and externally.
  • Oversee equipment qualifications including IQ, OQ, and PQ, as well as process validations.
  • Manage on-market design changes by performing impact assessments and executing action plans.
  • Conduct investigations and review boards for CAPAs, non-conformances, and other quality observations.
  • Prepare and support regulatory submission documentation and internal/external audits.
  • Write and revise standard operating procedures, forms, and related quality documents.

What we're looking for

  • Bachelor’s degree in engineering, science, or other technical areas.
  • 6+ years of relevant experience in the medical device industry.
  • 4+ years of Quality Assurance experience.
  • Strong understanding of regulations and standards for combination products and medical devices.
  • Working knowledge of 21 CFR 820, EU MDR 2017/745, ISO 13485, and ISO 14971.
  • Working knowledge of Design Control per 21 CFR 820.30.
  • Experience in product development, design control, and risk management.
  • Accreditation by a professional body such as ASQ CQA or CQE (preferred).

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