Senior Supplier Quality Engineer

Planet Pharma

  • Draper, UT
  • Today
  • $50–$51 Per Hour
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Skills

  • Aerospace and Defenseunmatched
  • Analysis Skillsunmatched
  • Code of Federal Regulationsunmatched
  • Corrective Actionunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cross-Functionalunmatched
  • Engineeringunmatched
  • Equipment Validationunmatched
  • Extrusionunmatched
  • FDA (Food and Drug Administration)unmatched
  • Failure Mode and Effects Analysis (FMEA)unmatched
  • Geometric Dimensioning and Tolerancingunmatched
  • ISO (International Organization for Standardization)unmatched
  • ISO 9001unmatched
  • Injection Moldingunmatched
  • Interpersonal Skillsunmatched
  • Machiningunmatched
  • Manufacturing/Industrial Processesunmatched
  • Medical Equipmentunmatched
  • Multitaskingunmatched
  • Problem Solving Skillsunmatched
  • Process Capabilityunmatched
  • Process Validationunmatched
  • Product Developmentunmatched
  • Product Supportunmatched
  • Product/Service Launchunmatched
  • Quality Assurance Methodologyunmatched
  • Quality Engineeringunmatched
  • Receiving Inspectionunmatched
  • Regulationsunmatched
  • Research & Development (R&D)unmatched
  • Riskunmatched
  • Risk Managementunmatched
  • Root Cause Analysisunmatched
  • Sales Qualificationunmatched
  • Test Designunmatched
  • Test Plan/Scheduleunmatched
  • Validation Testingunmatched
  • Vendor/Supplier Evaluationunmatched
  • Vendor/Supplier Quality Managementunmatched

Description

Senior Supplier Quality Engineer Location: Draper, UT (Relocation is not available; candidates must be local.)Contract Duration: 6 months (potential to extend)Pay Range: $50–51/hr.OPT and visa sponsorship are not available for this role.Position Overview The Senior Supplier Quality Engineer will play a key role in supporting critical product development and commercialization projects. This cross-functional role requires close collaboration with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering, and Receiving Inspection teams.The primary responsibility is to lead supplier parts qualification activities to ensure alignment with product development timelines and commercial launch goals. This position operates in a fast-paced, on-site environment where initiative and proactive problem-solving are essential.Key Responsibilities Lead and perform gage studies, process capability studies, and supplier process validations for critical components based on FMEA risk assessmentsDevelop and validate test methods, including inspection routines using optical measurement equipment and design of inspection fixtures using SolidWorksSupport Receiving Inspection with component test methods and investigation activitiesManage supplier non-conformances and drive resolutionOversee Supplier Corrective Action Requests (SCARs) from initiation through closureReport supplier part qualification status in cross-functional project meetingsCollect, analyze, and report supplier quality metricsCommunicate supplier quality risks to management and propose mitigation strategies during management reviews and project meetingsRequired Skills & Qualifications Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001, and other applicable international regulatory standardsExperience with Design Controls and test method development/validationProven experience in component testing, test method validation, and equipment validationStrong understanding of statistical tools and methods (Gage R&R, SPC, process capability studies)Experience conducting root cause analysis and managing CAPA processesKnowledge of GD&T and ability to interpret engineering drawingsUnderstanding of process validations (IQ, OQ, PQ)Familiarity with manufacturing processes (e.g., injection molding, extrusion, machining)Strong interpersonal skills with ability to influence and negotiateAbility to manage multiple priorities with strong attention to detailEffective collaboration in cross-functional and supplier-facing environmentsEducation & Experience Bachelor's degree in Engineering or a related scientific fieldMinimum 4 years of engineering experience in a highly regulated industry (e.g., medical device, aerospace, automotive)#J-18808-Ljbffr

Numbers & Facts

LocationDraper, UT
Salary$50–$51 Per Hour

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