Senior Quality Engineer, Medical Device & Combination Product Quality Systems

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.

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 ability to manage multiple commitments, with the support of other team members and management.