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.

SUMMARY:

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.

ESSENTIAL DUTIES

• 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.

COMPETENCIES

• 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

QUALIFICATIONS

Education/Experience Required:

• 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

Preferred:

• 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
• Certified quality auditor