Kestra Medical Technologies is a wearable medical device and digital healthcare company.
<div class="content-intro"><p>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.</p></div><section class="styles--3vx-H" data-ui="job-benefits"></section> <p style="text-align: left;">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.</p> <p> </p> <p><strong>ESSENTIAL DUTIES</strong></p> <ul> <li>Leads new and existing supplier audits, selection, development, and supports supply chain team strategies</li> <li>Participates in design reviews with development teams and suppliers to ensure manufacturable designs and</li> <li>definition of critical-to-quality/process/function parameters for critical components/sub-systems</li> <li>Manages supplier part/assembly qualifications using PFMEA/AQPQ/PPAP techniques</li> <li>Manages supplier process validation plans, and reports using IQ/OQ/PQ validation techniques</li> <li>Approves supplier test and inspection plans and procedures to ensure quality at the source</li> <li>Maintains supplier key performance indicators (KPIs) to support supplier score cards, and drive</li> <li>improvements.</li> <li>Drives supplier quality MRB dispositions, root cause determination, and 8D corrective actions/supplier</li> <li>corrective action requests (SCAR)</li> <li>Utilizes six-sigma and lean manufacturing techniques to lead continuous improvement of supplier</li> <li>performance working with supply chain and development teams</li> <li>Acts as supplier primary technical contact working both independently and in teams to support company</li> <li>objectives</li> <li>Maintains 100% compliance to Kestra Medical Quality Management System</li> <li>Responsible for technical project management of supplier Audit, PPAP, SCAR, and other deliverables to meet</li> <li>internal deadlines, and achieve objectives</li> </ul> <p><strong>COMPETENCIES</strong></p> <ul> <li>Passion: Contagious excitement about the company – sense of urgency. Commitment to continuous</li> <li>improvement</li> <li>Integrity: Commitment, accountability, and dedication to the highest ethical standards</li> <li>Collaboration/Teamwork: Inclusion of Team Member regardless of geography, position, and product or</li> <li>service</li> <li>Action/Results: High energy, decisive planning, timely execution</li> <li>Innovation: Generation of new ideas from original thinking</li> <li>Customer Focus: Exceed customer expectations, quality of products, services, and experience always present</li> <li>of mind</li> <li>Emotional Intelligence: Recognizes, understands, manages one’s own emotions and is able to influence</li> <li>others. A critical skill for pressure situations</li> <li>Ability to be a self-starter, seek new and better methods, and work with minimum supervision</li> <li>Capability to discern relevant facts and in turn, effectively resolve issues by making good decisions</li> <li>(compliance, quality, integrity, ethics, and critical thinking ability)</li> <li>Ability to be flexible in a fast-paced goal-oriented environment</li> <li>Demonstrates the understanding of deadlines and time limits, ability to accomplish goals, and the desire to win</li> </ul> <p> </p> <p><strong>QUALIFICATIONS</strong></p> <p><strong>Education/Experience Required:</strong></p> <ul> <li>Bachelor's degree in electrical engineering or material science, technical science or equivalent combination of</li> <li>education and directly relevant experience</li> <li>8+ years’ directly relevant experience, with prior experience in a FDA/cGMP or regulated environment</li> <li>Working knowledge of PPAP and IQ/OQ/PQ validation techniques</li> <li>Strong written and verbal communication skills</li> <li>Direct experience as a Manufacturing Engineer, Test Engineer, or Supplier Quality Engineer with the assigned</li> <li>commodities</li> <li>High level Excel or other statistical software skills for data analysis, problem solving and reporting</li> <li>Deep expertise in high-level quality systems best practices</li> </ul> <p><strong>Preferred:</strong></p> <ul> <li>8+ years of experience in FDA/regulated environment</li> <li>Team leadership and project management experience</li> <li>Contract manufacturing support/ PCBA manufacturing support</li> <li>Experienced with six-sigma and lean manufacturing techniques</li> <li>Direct experience working with injection molding, plastic film welding/bonding, over-molded cables, and/or</li> <li>Wire harness assembly</li> <li>Ability to translate quality improvements to cost savings</li> <li>Certified quality auditor</li> </ul> <p><strong>SUPERVISORY RESPONSIBILITIES:</strong></p> <ul> <li>None</li> </ul> <p><strong>WORK ENVIRONMENT:</strong></p> <ul> <li>Indoor open office environment</li> <li>Minimal noise volume typical to an office environment</li> <li>Extended/overtime hours when needed</li> <li>Kestra manufactures and provides life-saving products regulated by the Federal Food