Senior Quality Engineer, Design Quality - Lifecycle Management

AbbVie

Confirmed live yesterday 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 yesterday
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 within cross-functional teams to manage the transition of medical devices and combination products from development to manufacturing. The role involves executing Quality System requirements, maintaining Design History File documentation, performing risk management activities, and overseeing design change control for items like infusion pumps and autoinjectors. Key responsibilities include supporting equipment qualifications, managing third-party supplier activities, and leading investigations for CAPAs and non-conformances. Candidates must possess a technical degree and experience with 21 CFR 820, EU MDR 2017/745, ISO 13485, and ISO 14971. The position requires expertise in design control, process validation, and regulatory submission support to ensure products remain compliant with global regulations while navigating the complexities of medical device lifecycle management and manufacturing transitions.

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 systems.
  • Serve as the primary quality lead for product design transfers from development to manufacturing.
  • Oversee equipment qualifications, including IQ/OQ/PQ, and manage process validation activities.
  • Develop and execute change plans to manage on-market design changes and impact assessments.
  • Conduct investigations and review boards for CAPAs, non-conformances, and other quality issues.
  • Prepare for and support internal and external regulatory agency audits.
  • Write and revise standard operating procedures, forms, and related technical documentation.

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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