Position Details

Salary $65K – $104K USD / year

Type Full-Time

Experience mid

Exp. Years Not specified

Education Not specified

Category Engineering (Non-Software)

About this role

Quality Engineer supporting new product development in a healthcare manufacturing setting, responsible for verification, validations, and quality assurance activities.

Key Responsibilities

Lead design verification tests
Conduct process validations
Support NCR and calibration activities
Develop and maintain quality documentation
Ensure MDR/GSPR compliance

Technical Overview

Focus on quality engineering methods, risk analysis, design controls, MDR/GSPR compliance, and data-driven process improvement.

Ideal Candidate

The ideal candidate is a quality engineer with extensive NPD experience in a medical device context, proficient in design verification, process validation, risk analysis (AFMEA/DFMEA/PFMEA), and MDR/GSPR compliance, capable of leading quality activities across product lifecycles.

Must-Have Skills

Experience with design verification testsProcess validationsQuality System complianceDocumentation disciplineStatistical tools (Six SigmaSPCDOE)Design control requirements (Design Trace Matrix)MDR MDR/ GSPR complianceNCR processCross-functional collaboration

Nice-to-Have Skills

Regulated manufacturing environments (medical devices) experienceQualification of equipmentGXP complianceMDR/GSPR familiarity

Tools & Platforms

Six SigmaDOESPCAFMEADFMEAPFMEA

Required Skills

Design verification testsprocess validationsquality systemAFMEADFMEAPFMEASix SigmaSPCDOEdesign controlMDRGSPRNCR processcalibration

Hard Skills

Quality engineering toolsdesign verification testsprocess validationsAFMEADFMEAPFMEASix SigmaSPCDOEdesign controlMDRGSPRNCR processcalibrationtest equipment

Soft Skills

attention to detailproblem solvingcommunicationteam collaborationdocumentation

Industry & Role

Industry Healthcare & Medical

Job Function Support design verification, validations, and quality assurance for healthcare products in Irvine.

Role Subtype Engineering (Non-Software)

Keywords for Your Resume

Quality Engineer 2 NPDNew Product Developmentdesign verification testsprocess validationsQuality System policiesAFMEADFMEAPFMEASix SigmaSPCDOEdesign controlMDRGSPRNCR processcalibrationtest equipmentmedical devicesNCR

Deal Breakers

Not specified

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