OSI Systems, Inc

Manufacturing Quality Engineer 2

US-WA-Snoqualmie
2 weeks ago
Spacelabs Healthcare
Requisition #
12480

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 Manufacturing Quality Engineer (MQE) will support Manufacturing to ensure that the manufactured product performance is achieved meeting the applicable medical device regulatory requirements and company Policies & Procedures. The MQE will collaborate with Manufacturing Engineering to identify solutions that meet compliance and business requirements. This position is responsible to provide direction in the areas of Process Controls, Design Transfer, and Risk Management to cross-functional teams responsible for new product development, Manufacturing or design changes. The MQE is a part of a team driven to identify, develop and deliver innovative solutions, and constantly improve process capability and product quality while maintaining and improving quality standards. This will involve interfacing with the Operations, R&D, and Quality.

Responsibilities

  • Support all phases of Manufacturing including labeling, inventory control, product release, distribution, and non-conforming material.
  • Support product development and Manufacturing Engineering to ensure the effective transfer into production.
  • Ensure the appropriate test methods, statistical tools and sampling plans are utilized in production.
  • Support Manufacturing Engineering in process development, equipment selection, software and test method validation, process validation, process flow activities, and the appropriate use of statistical methodologies.
  • Review and approve technical documentation and acts as quality consultant for Quality Operations.
  • Advocate for regulatory and ISO Standard compliance in production activities.
  • Involved in post-market investigations, and provides reports on quality issues and production nonconformity as requested by management to support compliance and improvement objectives.
  • Support CAPA and risk management activities, including PFMEA’s.
  • 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 experience).
  • Minimum of 3 years of Quality or Manufacturing Engineering experience required (level 2; 5 years of Quality or Manufacturing Engineering experience required for a level 3); a suitable combination of education and experience will also be considered.
  • Ability to manage multiple, complex priorities within demanding timeframes.
  • Experience with one or more of the following:
    • 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
    • AQL, RQL, and variable sampling plans
    • Corrective and Preventive Actions

 

DESIRED:

    • Medical device manufacturing experience
    • Proficient with electronic QMS and ERP systems, e.g. Agile, MFG/Pro, CATSWeb
    • ASQ Certified Quality Engineer

 

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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