Sr Supplier Quality Engineer

Kestra Medical Technologies•Kirkland, WA

1d•Onsite

About The Position

The Senior Supplier Quality Engineer is responsible for working with Kestra's development team and external suppliers to deliver high quality, life-saving products throughout the product lifecycle. This role manages all aspects of tier one and sub-tier supplier quality activities for assigned suppliers/commodities, driving quality and process improvement. The engineer will assess, monitor, and ensure the continued adequacy and effectiveness of the quality system for the assigned supplier base, and will support supplier selection, supplier process validation/controls, and general supplier development. Additionally, the role involves reviewing and approving inspection sampling plans for selected 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.
Ability to be a self-starter, seek new and better methods, and work with minimum supervision.
Capability to discern relevant facts and in turn, effectively resolve issues by making good decisions (compliance, quality, integrity, ethics, and critical thinking ability).
Ability to be flexible in a fast-paced goal-oriented environment.
Demonstrates the understanding of deadlines and time limits, ability to accomplish goals, and the desire to win.

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.