Senior Quality Engineer, Medical Device & Combination Product Quality Systems

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

• 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.

Qualifications

• 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. 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. 
• The role operates with a moderate degree of autonomy & accountability, making independent quality & compliance decisions timely and demonstrating the a