About this role
Quality Engineer I provides QA support to manufacturing and new product development teams via investigations, validations, CAPA, and non-conforming materials, ensuring GMP/ISO13485 compliance and smooth tech transfer to manufacturing.
Key Responsibilities
- Nonconformance and CAPA activities
- Investigate and disposition nonconforming materials
- Attend Tier Meetings and engineering investigations
- Write qualification and validation plans
- Document changes (DCRs, Deviations)
Technical Overview
Regulatory-focused quality engineering with emphasis on CAPA, validation planning, design controls, and risk management in a manufacturing setting, including auditing and supplier oversight.
Ideal Candidate
The ideal candidate is a quality engineer with 1+ year in manufacturing quality, strong GMP/ISO13485 understanding, and capable of leading CAPA and nonconformance investigations in a regulated environment.
Must-Have Skills
BS in Engineering or related field1+ 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 GMPISO 13485 requirementsKnowledge of statistics and quality tools (SPCRisk AnalysisProcess CapabilityDOETQM methodsLean/Six-Sigma)
Nice-to-Have Skills
Sterilization and Process Validation experienceASQ Certification in Quality EngineeringPrevious Quality System auditing experience
Required Skills
BS in Engineering1+ years Manufacturing QualityNonconformanceCAPADesign prints readingFDA GMPISO 13485Statistical analysisSPCRisk AnalysisDOELean/Six-SigmaTier MeetingsEngineering InvestigationsQualification and Validation plansDCRsDeviationsQuality Systems auditing
Hard Skills
NonconformanceCAPAQuality SystemsFDA GMPISO 13485Risk ManagementDesign prints readingEngineering InvestigationsQualification and Validation plansQualificationValidationStatistical analysisDOEProcess ValidationInternal quality auditsSupplier auditsTier MeetingsDCRsDeviations
Soft Skills
Attention to detailCollaborationTeamworkCommunicationProblem-solvingDocumentationCross-functional teamwork
Certifications
Preferred
ASQ Certification in Quality Engineering
Keywords for Your Resume
Quality EngineerManufacturing QualityNonconformanceCAPAFDA GMPISO 13485Risk AnalysisSPCDOELean/Six-SigmaProcess ValidationEngineering InvestigationsQualification and Validation plansTier MeetingsSupplier auditsDCRsDeviationsQuality SystemsLean Six-Sigma
Deal Breakers
BS in Engineering (not satisfied), Less than 1 year experience, No knowledge of FDA GMP/ISO13485, Cannot read/interpret design prints, Not authorized to work in the US
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