Position Details

Salary $200K – $229K USD / year

Type Full-Time

Experience entry

Exp. Years 1+ years

Education BS in Engineering or related field of science

Category QA & Testing

About this role

Quality Engineer I at Baxter provides Quality Engineering support to manufacturing and new product development through investigations, validations, CAPA, non-conforming issues, and risk management activities.

Key Responsibilities

Nonconformance and CAPA activities
Site quality support and investigations
Support manufacturing improvements and validations
Initiate documentation changes (DCRs, Deviations)
Complaint investigations

Technical Overview

Focus on quality systems, CAPA, nonconformance, FDA GMP and ISO 13485 compliance; uses SPC and DOE; performs audits and risk analyses; collaborates with manufacturing and product development.

Ideal Candidate

An entry-level Quality Engineer I with 1+ year of quality experience in a GMP/ISO environment, familiar with CAPA, nonconformance, and basic statistical tools. They should be detail-oriented, able to read design prints, and capable of contributing to audits and validation activities.

Must-Have Skills

BS in Engineering or related field of science1+ years of experience in Manufacturing QualityDesign Assurance or Quality SystemsExperience managing non-conformance activities and owning corrective and preventative actionsAbility to read/interpret design printsWorking knowledge of FDA GMP and ISO 13485 requirementsKnowledge of statistics and quality tools such as SPCRisk AnalysisDOETQM methodsand Lean/Six-Sigma

Nice-to-Have Skills

Sterilization and Process Validation experienceASQ Certification in Quality EngineeringPrevious Quality System auditing experience

Tools & Platforms

FDA GMPISO 13485

Required Skills

BS in Engineering or related field of science; nonconformance; CAPA; FDA GMP; ISO 13485; SPC; DOE; Lean/Six-Sigma; risk management; validation

Hard Skills

FDA GMPISO 13485NonconformanceCAPAStatistical analysisSPCDOELean/Six-SigmaRisk analysisDocumentation (DCRsDeviations)Quality systemsAuditsTier MeetingsEngineering InvestigationsQualification and Validation

Soft Skills

Attention to detailProblem solvingCommunicationTeam collaboration

Certifications

Preferred

ASQ Certification in Quality Engineering

Industry & Role

Industry Healthcare & Medical

Job Function Provide quality engineering support to manufacturing and new product development through investigations, validations, and CAPA activities.

Role Subtype QA Engineer

Keywords for Your Resume

Quality Engineer IQuality engineeringNonconformanceCAPAEngineering InvestigationsQualification and ValidationValidation plansDOESPCLean Six-SigmaRisk managementTier meetingsProduct SurveillanceAuditsQA SystemsFDA GMPISO 13485DCRsDeviationsManufacturing qualityValidationLean Six Sigma

Deal Breakers

BS in Engineering or related field, 1+ year of relevant experience, Ability to read design prints

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