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 Supplier Quality Engineer is responsible for working with our development team and external suppliers to deliver high quality, lifesaving products; from development, through the life of the product. Manage all aspects of tier one and sub-tier supplier quality activities for assigned suppliers; drive quality and process improvement at assigned suppliers. Assess, monitor, and ensure the continued adequacy and effectiveness of the quality system for the assigned supplier base. Support supplier selection, supplier process validation/controls, general supplier development. Review and approve supplier and source inspection sampling plans.
Support new supplier audits, selection, development, and supply chain team strategies
Participate in design reviews with development teams and suppliers to ensure manufacturable designs
Participate in definition of critical-to-quality/process/function parameters for critical components/sub-systems.
Manage supplier part/assembly qualifications using PFMEA/AQPQ/PPAP techniques
Manage supplier process validation plans, and reports using IQ/OQ/PQ validation techniques
Approve supplier test and inspection plans and procedures to ensure quality at the source
Maintain supplier key performance indicators (KPIs) to support supplier score cards, and drive improvements.
Drive supplier quality MRB dispositions, root cause determination, and 8D corrective actions/supplier corrective action requests (SCAR)
Utilize six-sigma and lean manufacturing techniques to Lead continuous improvement of supplier performance working with supply chain and development teams
Supplier primary technical contact working both independently and in teams to support company objectives
Maintain 100% compliance to Kestra Medical processes and procedures.
Passion: Contagious excitement about the company – sense of urgency. Commitment to continuous improvement.
Integrity: Commitment, accountability, and dedication to the highest ethical standards.
Collaboration/Teamwork: Inclusion of Team Member regardless of geography, position, and product or service.
Action/Results: High energy, decisive planning, timely execution.
Innovation: Generation of new ideas from original thinking.
Customer Focus: Exceed customer expectations, quality of products, services, and experience always present of mind.
Emotional Intelligence: Recognizes, understands, manages one’s own emotions and is able to influence others. A critical skill for pressure situations.
Technical project management of supplier Audit, PPAP, SCAR, and other deliverables to meet internal deadlines, and achieve objectives
Ability to drive and deliver innovative, effective and timely solutions
Bachelor’s degree in Electrical, Industrial or Manufacturing Engineering, or related technical degree and equivalent business experience
Minimum 5 years of directly relevant experience
Working knowledge of PPAP and IQ/OQ/PQ validation techniques
Direct experience working Contract Manufacturers, and ODM Suppliers
Direct experience implementing supplier process controls and remote monitoring
Ability to drive and deliver innovative, effective, and timely solutions
8+ years of experience in FDA/regulated environment
Team leadership and project management experience
Experience implementing supplier process controls and remote monitoring systems
Experienced with six-sigma and lean manufacturing techniques
Kestra Medical Technologies is a wearable medical device and digital healthcare company that protects patients with diagnostic and therapeutic technologies that are intuitive, intelligent, and mobile. Kestra innovations empower providers and patients to collaborate towards better care and improved outcomes.
Kestra’s Mission is to provide innovative, intuitive medical technologies to protect and support at-risk patients.
Our Team of professionals with deep expertise in Class III therapeutic medical devices works together focused on our Core principles of innovation, collaboration, and execution.