At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients.
Why work at Spacelabs? Because lives depend on you!
The Supplier Quality Engineer (SQE) will provide leadership and guidance to cross-functional, multilevel technical teams to assure causes of product quality issues and non-conformances are identified and understood, and that sound corrective and preventive actions are implemented. This position supports supplier selection and approved supplier list (ASL) qualification. This individual will manage and document supplier corrective actions for systemic product quality and process issues identified through trending and quality system audits. The SQE is responsible for conducting audits per annual supplier schedule and driving investigation and corrective actions to closure. The SQE will ensure quality standards are in place and followed, develop and implement inspection strategies, and report on the current state of supplier’s performance, and keep management informed on a regular basis to ensure corrective/preventive action is taken where necessary.
Bachelor’s Degree in engineering or technical discipline (or non-technical degree with 4 years of experience)
Certified Quality Auditor (ISO 13485 lead auditor) or similar certification
5+ years of Quality Assurance experience in a regulated manufacturing environment, with at least 3 years in medical device manufacturing
Expert at Root Cause Analysis
Quality Management System tools and continuous improvement methodologies
FDA, ISO or EU Medical Device Directive (MDD)
Manufacturing standards, such as SPI Cosmetic Specifications of Injection Molded Parts and IPC-A-610 Acceptability of Electronic Assemblies
Interpreting Engineering Drawings
ANSI/ASQZ1.4-2008 Sampling Procedures and Tables for Inspection by Attributes.
Must travel (domestic and international) up to 25%, and be able to acquire all necessary travel documents.
Must be able to complete job responsibilities working with global time zone needs such as attending late night/early morning meetings by phone and/or web to meet global business needs.
OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for the Security and Healthcare divisions, as well as to external original equipment manufacturer clients for application in the defense, aerospace, medical and industrial markets, among others.
OSI Systems companies have a long history of developing innovative solutions to bring a better quality of life to the world. Healthcare, security and defense are among the key markets where we have made significant inroads with new ideas, products and processes. We know that many people live in difficult and dangerous conditions. To improve these circumstances, experts need simple, effective tools... utilizing the latest in technology.
As a global company, we are dedicated to developing these tools for our customers and the people they serve worldwide. Our singular focus is to help security experts, clinical professionals and high-tech developers solve real-world problems and issues. Our OSI Optoelectronics (OSIO) division is a diversified manufacturer of electronic devices and value-added manufacturing services for use in a broad range of applications, including aerospace and defense electronics, security and inspection systems, and medical monitoring and diagnostics.