OSI Systems, Inc

  • Product Quality Engineer

    Location US-WA-Snoqualmie
    Posted Date 1 month ago(5/7/2018 10:25 AM)
    Company
    Spacelabs Healthcare
    Requisition #
    13660
  • 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 Product Quality Engineer for Supplies and Accessories includes aspects of Supplier Quality and Program Management. This position will have leadership, oversight of multilevel technical teams to assure product changes, causes of product quality issues, and non-conformances are reviewed and understood

    Responsibilities

    • Implements and execute quality plans to monitor and improve the supply chain, ensuring quality components that meet specifications in the most effective and efficient manner
    • Support Investigation efforts, as required, to address and reduce customer complaints through effective root cause investigation and corrective action.
    • Support Corrective Action and Preventive Actions as well as Supplier Corrective Actions Identified in the S&A area to ensure timelines are met
    • Implements product quality improvements and manages site Product Quality Team activities
    • Support S&A related Internal audits, as well as FDA and Notified Body external audits
    • Engage in continuous process improvement of S&A products through measurement and evaluation
    • Implement and execute quality plans to monitor and improve the supply chain, ensuring quality components that meet specifications. Establish all QMS and regulatory requirements with assigned suppliers and ensure they are met.
    • Participate in design quality activities; develop and implement part and process qualification requirements to ensure that delivered products meet specification and quality/reliability requirements.
    • Recommend and implement supplier improvement plans. Develop requirements, specifications, schedules, risk analysis, and tradeoff analysis.
    • Support development of incoming product strategy, First Article Inspections, and investigation and disposition of nonconforming materials.
    • 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 Spacelabs Healthcare 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 relevant experience)
    • 3 + years in Medical Device Manufacturing preferred
    • Experience with Root Cause Analysis
    • Highly Desired Experience in the following:      
      • Quality Management System tools and continuous improvement methodologies
      • FDA, ISO or EU Medical Device Directive (MDD)
      • Interpreting Engineering Drawings
    • Ability to manage multiple, complex priorities within demanding timeframes. Strong project management skills.
    • Proven ability to deliver results through others, both direct and matrixed.  Proven ability to lead, develop, motivate and hold others accountable.
    • Self-motivated and organized.
    • Experience working positively and productively in a team environment. Highly collaborative.
    • Experienced user in PowerPoint, Excel, and Word required.  
    • Must travel (domestic and international) 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.

                           

    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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