Senior Manager, RDQA

AbbVie

Confirmed live today High trust

Quick summary

Work type
On-site
Location
Branchburg, NJ
Salary
$124,500–$236,500 / yr
Posted
5 days ago
Freshness
Confirmed live today
Closes
Sep 16, 2126

Market check

Salary context

Competitive pay

How this pay compares to similar roles

Similar $201k
This role $180k
$111k most similar roles pay here $252k

This role pays less than 64% of similar roles. Most pay $177,837–$223,750 — the shaded band above. At the midpoint, this role pays about $180k versus about $201k for comparable roles.

Based on 239 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 354 open roles on FindRole.

Listed pay typically runs $109,500–$208,500 across 321 roles with salary data.

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At a glance

TL;DR · Senior Manager, RDQA

The Senior Manager, RDQA supports the development of medical devices and components for combination products by providing direction on design control, human factors, usability engineering, and risk management processes. This role involves engaging with cross-functional teams to ensure design systems are effectively executed while performing hazard analysis and design failure mode effect analysis. The individual will translate design requirements into manufacturing requirements, lead reliability activities like capability analysis and requirement flow down, and provide quality oversight for clinical batch manufacturing. Key technical competencies include expertise in 21 CFR Part 820, ISO 13485, ICH Q9, ISO 14971, and IEC/EN 62366 standards. The role addresses the complex challenge of ensuring medical device products comply with global regulations while maintaining high performance through robust engineering, statistical process control, and corrective action investigations within a regulated pharmaceutical and medical device environment.

What you'll do

  • Provide guidance on design control, human factors, and risk management for medical device products.
  • Review design documentation for safety risks, manufacturability, biocompatibility, and reliability requirements.
  • Translate product design requirements into manufacturing requirements to ensure successful production.
  • Lead root cause analysis and develop corrective actions for technical problems.
  • Facilitate Design, Manufacturability, and Reliability (DRM) activities including capability analysis and requirement flow down.
  • Ensure all products comply with FDA Quality System Regulations and ISO 13485 standards.
  • Provide quality oversight for clinical batch manufacturing, equipment qualification, and data traceability.
  • Serve as a subject matter expert during regulatory audits and inspections.

What we're looking for

  • 10+ years of experience in the Medical Device industry and 2+ years in project management.
  • Minimum of a BS in Engineering or Scientific discipline; MS preferred.
  • Proven expertise in compliance with regulations including 21 CFR Part 820, ISO 13485, ICH Q9, and ISO 14971.
  • Expertise in human factors/usability engineering standards such as IEC/EN 62366 and ANSI HE75.
  • Skilled in requirements analysis, reliability analysis, test method validation, and technical report writing.
  • Experience interacting with regulatory agencies and notified bodies.
  • Knowledge of quality tools including CAPA, statistical process control, FMEA, and DOE.
  • Ability to influence others and collaborate with internal and external partners.

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