Sr Supplier Quality Engineer

Kestra Medical Technologies, Inc•Kirkland, WA

1d•$140,000 - $150,000

About The Position

The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable technologies with proven device therapies. Kestra’s solutions combine high quality and technical performance with a wearable design that provides the greatest regard for patient comfort and dignity. Innovating versatile new ways to deliver care, Kestra is helping patients and their care teams harmoniously monitor, manage, and protect life. The Senior Supplier Quality Engineer is responsible for working with our development team and external suppliers to deliver high quality, life-saving products; from development, through the life of the product. Manages all aspects of tier one and sub-tier supplier quality activities for assigned suppliers/ commodities; drives quality and process improvement at assigned suppliers/commodities. Assesses, monitors, and ensures the continued adequacy and effectiveness of the quality system for the assigned supplier base. Supports supplier selection, supplier process validation/controls, general supplier development. Reviews and approves inspection sampling plans for selection parts.

Requirements

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

Nice To Haves

8+ years of experience in FDA/regulated environment
Team leadership and project management experience
Contract manufacturing support/ PCBA manufacturing support
Experienced with six-sigma and lean manufacturing techniques
Direct experience working with injection molding, plastic film welding/bonding, over-molded cables, and/or Wire harness assembly
Ability to translate quality improvements to cost savings
Certified quality auditor

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