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OSI Systems, Inc. Quality Assurance Specialist 3 in Snoqualmie, Washington

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 Quality Assurance (QA) Specialist ensures that the quality management system for the organization effectively supports 21 CFR Part 820, ISO 13485 and other relevant standards. The individual is responsible for introducing and maintaining quality system procedures, system improvements, corrective and preventive actions (CAPA), internal audits, nonconforming material reports (NMR), change orders, training, product structuring and unique device identifier labeling.

  • Participates in cross-functional compliance to quality system requirements

  • Participates and/or develops and monitors key performance indicators; recommends solutions and engages in continuous improvement activities

  • Develops and/or generates metrics to support management reporting requirements

  • Develops and/or supports business acquisition strategies and quality plans

  • Creates and maintains required quality system documents and records, including summaries and management reports

  • May function as a subject matter expert for FDA and Notified Body external audits

  • Evaluates the effectiveness and efficiency of regulated processes throughout the organization and makes recommendations for improvement

  • Assists in preparation and follow up for Management Review meetings; may be a presenter

  • Generates and/or conducts process evaluations

  • Supports and/or functions as a Lead Auditor for Internal Audits

  • Acts as, or supports, the CAPA QA Owner; investigates, documents, reports, and tracks the root cause of quality issues

  • Supports and/or facilitates quality system tool updates (plan, protocol, report)

  • Processes, generates change orders; functions as a change analyst

  • Provides Agile User Training

  • Supports and/or conducts the Agile Change Control Board and the Business Change Control Board

  • Evaluates new device requests and/or updates that require Global Trade Identification Numbers (GTIN); assigns numbers, as required

  • Maintains regulatory GTIN databases, i.e. GUIDID (FDA), EUDAMED (EU), etc., as required for medical device maintenance

  • Supports and/or facilitates nonconforming material reports; processing and closure

  • Coordinates and/or conducts Material Review Board meetings and investigations

  • Supports and/or facilitates Training role and curriculum changes in ComplianceWire

  • Supports and/or facilitates process deviations

  • Supports and/or generates quality system software requirements and validation protocols

  • 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

    • Bachelor of Science in Engineering, or 4 years of equivalent professional experience

Medical Device Experience

  • Level III = 6+ years’ of experience working in quality, manufacturing or engineering disciplines in the medical device industry

  • Level II = 3+ years’ of experience working in quality, manufacturing or engineering disciplines in the medical device industry

  • Level I = 1 year of experience working in quality, manufacturing or engineering disciplines in the medical device industry

Quality Assurance Experience

  • Level III = 6+ years’ experience with CAPA, NMR, Quality System Process Management and Change Control; ISO 13485 Lead Auditor Certification

  • Level II = 3+ years’ experience with CAPA, NMR, Quality System Process Management and/or Change Control; ISO 13485 Auditor Training or other equivalent experience

  • Level I = 1 year experience, or knowledge of CAPA, NMR, Quality System Process Management and Change Control

  • Ability to communicate effectively with staff at all levels of the organization

  • Demonstrated excellence in planning, executing, and project management


  • ASQ certifications in ISO 13485 and 21CFR 820 Compliance of medical devices

  • Deep understanding of statistical analysis and six sigma methodology

  • Experience operating under design control and Good Manufacturing Practices

  • Proficiency with Microsoft Office, Oracle Agile PLM, ComplianceWire

  • Ability to manage activities and quality control initiatives through timelines to meet corporate goals


OSI Systems, Inc. and its subsidiaries (collectively “OSI”) does not accept unsolicited resumes from recruiters or employment agencies. If any person or entity, including a recruiter or agency, submits any information, including any resume or information regarding any potential candidate, without a signed agreement in place with OSI, OSI explicitly reserves the right to use such information, and pursue and/or hire such candidates, without any financial obligation to the person, recruiter or agency. Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI.

Equal Opportunity Employer

EEO is the Law

Poster Link:

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.

Requisition #: 20229

External Company URL:

Street: 35301 SE Center Street