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Kestra Medical Technologies, Inc. · 8 hours ago

Sr Supplier Quality Engineer

Kirkland, WA

Full-time

Onsite

Senior Level, Lead/Staff

$140K/yr - $150K/yr

8+ years exp

Kestra Medical Technologies, Inc. is a company focused on innovating wearable technologies for cardiac medical devices. The Senior Supplier Quality Engineer is responsible for managing supplier quality activities, ensuring high-quality product delivery, and driving process improvements in collaboration with development teams and suppliers.

Health CareHealth DiagnosticsMedical Device

Growth Opportunities

No H1B

Responsibilities

Leads new and existing supplier audits, selection, development, and supports supply chain team strategies

Participates in design reviews with development teams and suppliers to ensure manufacturable designs and definition of critical-to-quality/process/function parameters for critical components/sub-systems

Manages supplier part/assembly qualifications using PFMEA/AQPQ/PPAP techniques

Manages supplier process validation plans, and reports using IQ/OQ/PQ validation techniques

Approves supplier test and inspection plans and procedures to ensure quality at the source

Maintains supplier key performance indicators (KPIs) to support supplier score cards, and drive improvements

Drives supplier quality MRB dispositions, root cause determination, and 8D corrective actions/supplier corrective action requests (SCAR)

Utilizes six-sigma and lean manufacturing techniques to lead continuous improvement of supplier performance working with supply chain and development teams

Acts as supplier primary technical contact working both independently and in teams to support company objectives

Maintains 100% compliance to Kestra Medical Quality Management System

Responsible for technical project management of supplier Audit, PPAP, SCAR, and other deliverables to meet internal deadlines, and achieve objectives

Qualification

FDA/cGMP experiencePPAP techniquesIQ/OQ/PQ validationSupplier quality managementSix Sigma techniquesLean manufacturingStatistical softwareQuality systems best practicesTechnical project managementCommunication skillsProject managementTeam leadership

Required

Bachelor's degree in electrical engineering or material science, technical science or equivalent combination of education and directly relevant experience

8+ years' directly relevant experience, with prior experience in a FDA/cGMP or regulated environment

Working knowledge of PPAP and IQ/OQ/PQ validation techniques

Strong written and verbal communication skills

Direct experience as a Manufacturing Engineer, Test Engineer, or Supplier Quality Engineer with the assigned commodities

High level Excel or other statistical software skills for data analysis, problem solving and reporting

Deep expertise in high-level quality systems best practices