UDI Change Analyst
in US - WA - Snoqualmie
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 UDI Change Analyst will oversee/assist in the creation of Engineering Change Orders (ECOs). The Change Analyst must ensure all ECO and Document Control processes are rigorously followed and all regulatory requirements per 21 CFR Part 820, ISO 13485, and that Spacelabs Healthcare procedures are satisfied prior to finalizing all ECOs. Also, maintains, archives and research of hardcopy legacy documents. The UDI Change Analyst assists with system upgrades and enhancements and is also responsible for conducting regular system maintenance as required.
- Monitors Change Control processes, procedures and practices, and ensures Engineering Change Orders comply with regulatory standards and the Spacelabs Healthcare quality management system.
- Assists with the review of Engineering Change Orders for compliance with applicable procedures, work instructions and forms.
- Assists with reviewing and creating ECO work instructions.
- Assists with the maintenance of the Unique Device Identifier (UDI) program
- Updates and maintains global CA work instructions, as required.
- Troubleshoots Agile PLM ECO Originator issues.
- Researches and reports ECO metrics.
- Conducts Agile tutoring and training.
- Works with IT and the Quality Systems Manager on system upgrades and enhancements.
- Functions as the primary point-of-contact for users of Agile for their business area.
- Responsible for department offsite storage
- Escalates problems to Quality Systems Supervisor as and when required.
- 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
- HS diploma or equivalent is required.
- Minimum of 3 years’ experience working within a regulated environment. (Level determined by overall experience)
- Experience with UDI desirable.
Must have experience following written instructions.
- Technical writing experience is a plus.
- Experience with Agile preferred.
- Proficiency with MS Office and other common business applications.
- Ability to deal with frequent changes, delays or unexpected events.
- Must be very detailed-oriented with ability to effectively multi-task.
- Excellent communication and presentation skills with demonstrated ability to effectively communicate at all levels of an organization.
Equal Opportunity Employer
EEO is the Law
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.