Engineer, QA II - Supplier Quality

About the role

AbbVie is looking for an Engineer, QA II to support and follow up on suppliers so that quality-relevant materials and services meet specifications and company requirements. The role keeps approved suppliers compliant, documents the process to meet regulatory and QMR03 Supplier Controls requirements, and coordinates with other parts of the company.

Key responsibilities

• Support and follow up suppliers; keep approved suppliers compliant and document the process for regulatory and QMR03 Supplier Controls requirements.
• Coordinate with other areas of the company to comply with its procedures and goals.
• Open, notify and track SCARs (supplier corrective actions); approve supplier corrective actions and confirm that committed activities were met.
• Notify suppliers of alerts based on trend analysis, supplier metrics, manufacturing defects or complaints, and follow up on them when needed.
• Track blocked, on-hold and quarantined materials and define and execute material disposition of non-conforming materials.
• Update and review supplier quality metrics, present monthly data to management, and encourage suppliers to complete periodic reviews such as Quality Agreements (QTA), quality questionnaires (QQ), supplier audits and supply chain maps.
• Track the annual schedule of supplier audits (on-site or questionnaire) and present audit results to management.
• Provide corporate auditors with supplier performance, SCARs, certificates of conformity, material specifications and receiving verification information, and carry out actions resulting from supplier audits.
• Keep the Approved Supplier List in GTW and the S/4 system updated after supplier qualifications, change controls and new material qualifications.
• Train contractors and consultants on quality standards, requirements and GMPs.
• Handle other duties assigned by the supervisor, including opening or closing actions on deviations, NCs, CAPAs, DCCs, CCs, AIAs, OMR presentations and internal audit responses.

Required profile

• Bachelor's degree in electrical, mechanical, electronic, electromechanical, industrial, biotechnology, chemistry, computer science or a related field, or equivalent experience in supplier quality roles.
• 1 year of experience in regulated industries; expertise in supplier quality management is a plus.
• English at B1 level.

Required skills

• Knowledge of root cause determination tools such as DMAIC or A3.
• Advanced knowledge of Windows office applications.
• Clear written and oral communication, critical thinking and continuous improvement.