AbbVie · 5 hours ago
Senior Quality Engineer, Medical Device & Combination Product Quality Systems
North Chicago, IL
Full-time
Onsite
Senior Level
5+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions to address serious health issues. The Senior Quality Engineer will support external and internal audits, ensure compliance with regulations, and lead quality management system processes for medical devices and combination products.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Supports External Audits in Front Room or Back Room lead capacities, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits under MDSAP
Conduct Internal Audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP
Subject Matter Expert in both current and emerging regulations and standards impacting AbbVie medical device and combination products, performing regulatory compliance assessments to support business decision-making
Serves as Process Owner of QMS process of moderate complexity, advancing process sustainment & improvement independently through effective project management
Performs root cause investigation and corrective action planning in response to external and internal audit observations of moderate risk, in collaboration with departmental process owners and subject matter experts
Qualification
Required
Bachelor's degree, preferably in engineering, physical science (e.g. Chemistry), life science (e.g. Microbiology or Biology) or pharmacy and a minimum of 5 years of industry experience in a GXP regulated environment
ISO 13485 Lead Auditor certification by a professional body is preferred
The role operates with a moderate degree of autonomy & accountability, making independent quality & compliance decisions timely and demonstrating the ability to manage multiple commitments, with the support of other team members and management
Preferred
Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Quality Engineer (CQE), Six Sigma Certification, or Project Management Professional (PMP) Certification
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
Labiotech UG
2026-02-07
Pharma Letter
2026-02-06
Company data provided by crunchbase