OSI Systems, Inc

  • Sr. Supplier Quality Engineer

    Location US-WA-Snoqualmie
    Posted Date 5 days ago(6/13/2018 12:12 PM)
    Company
    Spacelabs Healthcare
    Requisition #
    14177
  • Overview

    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 Senior Supplier Quality Engineer will lead and implement quality initiatives within the Global Quality Operations Team. Manage and document the activities internal to Spacelabs Healthcare related to suppliers on product quality issues. This position is a key partner to ensure accountability and quality performance from our suppliers is appropriately communicated. This role will work in conjunction with the Supply Chain team. Key success measurements include the ability to effectively work with Supply Chain, suppliers, and manage supplier quality from qualification to end-of-life for assigned products.

    Responsibilities

    • Implement and execute quality plans to monitor and improve the supply chain, ensuring quality components that meet specifications. Establish QMS and regulatory requirements in conjunction with Supply Chain with assigned suppliers.
    • Perform or manage on-site supplier audits.
    • Develop and maintain metrics to trend and report supply chain quality issues, and use them to launch timely response, as required, or provide information so that is can be sent.
    • Recommend and implement supplier improvement plans. Develop requirements, specifications, schedules, risk analysis, and tradeoff analysis.
    • Manage supplier corrective action requests to closure, and train internal team members on SCAR requirements.
    • Support development of incoming product strategy and investigation and disposition of nonconforming materials.
    • Serve as Quality Representative on MRB.
    • Partner with R&D and Operations to integrate supplier quality requirements into New Product Development and Operations Engineering projects.
    • Act as a mentor to SQEs on statistical analysis, and effective supplier quality processes and methodologies.
    • Ensure contract resources are effectively managed and deliver services and products as promised, and that meet our QMS requirements.
    • Develop and implement part and process qualification requirements to ensure that delivered products meet specification and quality/reliability requirements. Ensure that verification processes are trained, implemented, measured and effective.
    • Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork
    • Demonstrate behavior consistent with the company’s Code of Ethics and Conduct
    • It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem
    • Duties may be modified or assigned at any time to meet the needs of the business.

    Qualifications

    • Bachelor’s Degree in engineering or technical discipline (or non-technical degree with 4 years of experience)
    • Certified Quality Auditor
    • 8+ years of Quality Assurance experience in a regulated manufacturing environment, with at least 5 years in medical device manufacturing
    • Expert at Root Cause Analysis
    • Experienced with at least 3 of the following:
      • Quality Management System tools and continuous improvement methodologies
      • FDA, ISO or EU Medical Device Directive (MDD)
      • Process Validation
      • 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.
    • Ability to manage multiple, complex priorities within demanding timeframes. Strong project management skills.
    • Highly developed relationship-building skills, and strong presentation and communication skills.
    • Experience working positively and productively in a team environment. Highly collaborative.
    • Proven ability to deliver results through others, both direct and matrixed.  Proven ability to lead, develop, motivate and hold others accountable.
    • Experienced user in PowerPoint, Excel, and Word required.  
    • Six Sigma certification desired.
    • Some travel (domestic and international) and be able to acquire all necessary travel documents.
    • Must be able to support 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.

     

    Equal Opportunity Employer

     

    EEO is the Law

     

    Poster Link: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf

     

    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 original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.

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