Position Details

Type Full-Time

Experience senior

Exp. Years 6+ years of overall experience in Manufacturing, Quality or Engineering

Education Bachelor's degree, preferably in Biology, Chemistry or Engineering

Category Engineering (Non-Software)

About this role

This Senior Quality Engineer role supports Combination Products External Quality by managing assigned supplier/contract manufacturer quality. The position focuses on timely product delivery, compliance to AbbVie requirements and external regulations, and driving corrective actions through SCARs, CAPA, inspections, and quality planning.

Key Responsibilities

Support supplier quality development projects and continuous improvement activities
Investigate/coordinate supplier quality issues resolution and disposition non-conforming product
Initiate and follow up on Supplier Corrective Action Requests (SCARs) and validate corrective actions
Develop receiving inspection test methods, sampling plans and acceptance criteria including first article inspection
Develop and implement product quality plans, specifications, risk analyses and FMEAs aligned to ISO and regulatory requirements

Technical Overview

Work includes investigating and resolving supplier quality issues (non-conforming product, deviations, event/market complaints), initiating Supplier Corrective Action Requests (SCARs), validating corrective actions involving design/process changes, and developing receiving inspection test methods, sampling plans, acceptance criteria, and first article inspections. Quality system compliance is required across ISO 13485, CFR 820 QSMR, EU MDR, and ISO 14971, including support for Regulatory or Notified Body audits and creation of risk analyses and FMEAs.

Ideal Candidate

The ideal candidate is a senior quality professional with 6+ years of experience in manufacturing, quality, or engineering, focused on external supplier/contract manufacturer quality for combination products. They can lead SCARs and CAPA execution, validate supplier corrective actions, develop inspection and sampling plans, and build quality documentation aligned to ISO 13485, CFR 820 QSMR, EU MDR, and ISO 14971.

Must-Have Skills

quality/compliance knowledgeSupplier Corrective Action Requests (SCARs)CAPA for monthly quality reviewISO 13485CFR 820 QSMREU MDRISO 14971first article inspectionreceiving inspection test methodssampling plans and acceptance criteria

Nice-to-Have Skills

FMEAsrisk analysessupplier qualification activities

Required Skills

supplier quality development projectscontinuous improvementsupplier quality issues resolutiondispositioning of non-conforming producteventdeviationmarket complaintsSupplier Corrective Action Requests (SCARs)supplier corrective actionsdesign changesprocess changesreceiving inspection test methodssampling plansacceptance criteriafirst article inspectionstrategic supplier performancetrend analysisCAPAmonthly quality reviewmetricsquality reportsproduct quality plansquality specificationsquality plansrisk analysesFMEAsISO 13485CFR 820 QSMREU MDRISO 14971Regulatory or Notified Body auditsquality agreementssupplier qualification activitiesproject execution within defined time/cost parameters

Hard Skills

supplier quality development projectscontinuous improvementsupplier quality issue resolutiondispositioning of non-conforming producteventdeviationmarket complaintsSupplier Corrective Action Requests (SCARs)supplier corrective actionsdesign changesprocess changesreceiving inspection test methodssampling plansacceptance criteriafirst article inspectionstrategic supplier performancetrend analysisCAPAmonthly quality reviewmetricsquality reportsproduct quality plansquality specificationsquality plansrisk analysesFMEAsEuropean regulationsUS regulationsCanadian regulationsquality system requirementsquality system complianceISO 13485CFR 820 QSMREU MDRISO 14971Regulatory or Notified Body auditsquality agreements with supplierssupplier qualification activitiesproject execution within time/cost parameterscompliance to external regulations and standards

Soft Skills

Good verbal and written communication skillsGood problem solving and analytical skillsGood interpersonal relations / communications skillsGood negotiation skillsliaise with internal customerscross-functional collaborationproject delivery

Industry & Role

Industry Healthcare IT

Job Function Assure external supplier/contract manufacturer quality and compliance for combination products by leading inspections, SCARs, CAPA, and quality system documentation

Role Subtype Quality Engineer

Keywords for Your Resume

Senior Quality EngineerCombination Products External Qualitysupplier quality development projectscontinuous improvementsupplier quality issues resolutiondispositioning of non-conforming productdeviationmarket complaintsSupplier Corrective Action Requests (SCARs)SCARssupplier corrective actionsdesign and/or process changesreceiving inspection test methodssampling plansacceptance criteriafirst article inspectionstrategic supplier performancetrend analysisCAPAproduct quality plansquality specificationsquality plansrisk analysesFMEAsISO 13485CFR 820 QSMREU MDRISO 14971Regulatory or Notified Body auditsquality agreementssupplier qualification activitiestime/cost parametersnon-conformance trends

Deal Breakers

Must have knowledge of quality/compliance including ISO 13485, CFR 820 QSMR, EU MDR, and ISO 14971, Must have experience initiating and following up on Supplier Corrective Action Requests (SCARs), Must have experience with CAPA and supplier corrective actions involving design and/or process changes

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