OSI Systems, Inc

  • Product Complaint Specialist

    Location US-WA-Snoqualmie
    Posted Date 2 months ago(4/25/2018 8:21 PM)
    Company
    Spacelabs Healthcare
    Requisition #
    13659
  • 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 Complaint Specialist III will be responsible for receiving, evaluating, processing and researching to root cause or failed subsystem, the customer/product complaints for Spacelabs Healthcare manufactured and distributed products as required by regulatory standards and company policy. This position requires understanding of FDA regulatory obligations and compliance within the scope of 21 CFR part 820.198, as well as familiarity with report ability evaluation (RE’s) and Medical Device Reporting (MDR’s) as well as a good working knowledge of electronic circuits and network infrastructures. Ensuring compliance with all company policies, procedures and guidelines is essential at all times. Product Issue Specialist III will also be responsible to perform investigations into possible patient risk or incident reports. This will entail ability to clinically interact with field personnel as well as clinical staff.

     

    Responsibilities

    • Partners with sales, marketing, R&D, Field Service Engineers and manufacturing departments to resolve product problems and provides feedback to customers as needed.
    • Handles complaints received according to regulatory requirements, and Spacelabs policy and quality systems requirements. Complaint documentation must be thorough and complete, detailing sample requests, receipt, evaluation, and investigation.
    • Accountable for outstanding service to all external and internal customers.
    • Takes initiative and action to respond, resolve, and follow up on all customer/product complaints in a timely manner. Communicates directly with customers to gather additional information required for Reportability evaluations, Medical Device Records (MDR’s) and complaint initiation/investigations, including the retrieval of product samples and equipment for evaluation. Notifies customer of receipt of product inquiry/complaint and provides support as required.
    • Assures complaints from written, electronic, and oral communications are entered into the complaint handling data base in accordance with procedure. Confirms appropriate product complaint symptom codes are used based on the information available, and updates these codes as required when more information is discovered.
    • Performs and assists timely completion of investigations, completion of all complaint tasks and ensures that the required information is contained in the record prior to submitting for closure.
    • Applies knowledge of medical device regulatory requirements in order to support the MDR reporting process and identifying reportable events as they are received.
    • Ensures appropriate escalation of issues that cannot be resolved or that require management intervention in a timely manner, facilitating smooth transition of all such issues within the team, or to external departments as appropriate.
    • Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints when requested or required. Creates reports/metrics/graphs and presentation material for management.
    • Ability to write clear and concise response letters to customers concerning incidents involving Spacelabs products.
    • Travel into customer accounts may be required, but is not expected to exceed 5%.
    • 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 biomedical engineering, or related technology degree; or 4 years related experience.
    • Minimum of 5 years work experience with medical devices, or experience in complaint handling.
    • Incident/Escalation, Management and demonstrated experience supporting and troubleshooting networked medical devices deployed throughout hospital systems is highly desired.
    • Experienced user in Windows and Microsoft Office is essential
    • Excellent interpersonal and communication skills written and verbal, demonstrated by the ability to: listen and empathize with others; convey confidence; provide exemplary levels of service; resolve conflict effectively; collaborate with and facilitate small groups. Exceptional writing and oral communication skills – be able to convey complex information in clear executive summaries for diverse audiences.
    • Candidates should have a passion for providing extraordinary customer service and a knack for diffusing tense customer situations, putting customers at ease and instilling them with confidence in our ability and attention to detail
    • Demonstrated success as a highly creative, skilled technologist and problem solver with the skill set to drill a problem down to a root cause or subsystem level.
    • Team player who demonstrates positive, constructive interpersonal and strong organizational skills.
    • Self-motivated and able to work productively with minimal direction.
    • Customer Product Issue Specialist III will also require high skill level in written and oral communication involving customer responses, both in the form of letters as well as investigations.

      

          

    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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