QA II Engineer - Supplier Quality

About the role

AbbVie is hiring a QA II Engineer in Heredia, Costa Rica, 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 according to regulatory agency and QMR03 Supplier Controls policy needs, and coordinates with other areas of the company.

Key responsibilities

• Support and follow up suppliers to ensure materials and services meet specifications and company requirements, keeping approved suppliers compliant and documenting the process.
• Open, notify and track SCARs (supply corrective actions) with suppliers, approve corrective actions and confirm that committed activities were met with submitted evidence.
• Notify suppliers of alerts based on trend analysis, supplier metrics or defects found during manufacturing or complaints, and follow up on them when needed.
• Track blocked, on-hold and quarantined materials, define and execute material disposition of non-conforming materials, and update and review supplier quality metrics, presenting monthly data to management.
• Encourage suppliers to complete qualification reviews such as Quality Agreements (QTA), quality questionnaires (QQ), supplier audits, supply chain maps and change notifications, and coordinate their completion and submission.
• Track the annual schedule of supplier audits (on-site or quality questionnaire), present monthly audit results to management, and provide incoming audit auditors with the information they need.
• Maintain the ASL (Approved Supplier List in GTW) and S/4 system up to date, train contractors and consultants on quality standards, requirements and GMPs, and handle other duties assigned by the supervisor, including opening or closing actions related to deviations, CAPAs, DCCs, internal audit responses and more.

Required profile

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

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.