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 Systems Specialist is responsible for maintaining the Internal Audit and Unique Device Identifier (UDI) programs. These activities include: ensuring compliance to applicable standards and regulations associated with these functional areas, process development and maintenance, and employee development and supervision.
Maintain Spacelabs Unique Device Identifier (UDI), Internal/External Audit programs. Identify and execute system improvements, and write change orders as required to ensure compliance to all relevant regulations and standards.
Maintain FDA product code lists, as defined by Regulatory Affairs
Maintain GMDN code lists, as defined by Regulatory Affairs
Maintain Global Trade Identification Numbers for all Spacelabs Healthcare products
Maintain GS1 subscriptions
Assist with conformity assessment audits of policies, procedures and quality systems to identify non-conformities and ensure prompt and effective corrective actions are accomplished.
Maintain internal audit schedule
Assist Manager with group goals and objectives as well as cross-functional goals and objectives; ensures progress towards goals is met.
Uphold the Company’s core values of Code of Ethics and Conduct, and applicable compliance policies.
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.
5+ years of experience with medical device regulatory and quality systems or equivalent experience
2+ years of experience as a Lead Auditor or equivalent experience
Lead Auditor certification required
1+ year of Unique Device Identifier experience and/or configuration management desirable
Ability to communicate effectively over the telephone, in person, and in written form; with staff at all levels of the organization. Ability to present to large audiences desirable.
Creative problem solving, flexibility, and good negotiation skills
Ability to multi task and drive practical results to a timely conclusion
Self-motivated and organized
Competency in computer skills: MS Office applications, Agile PLM or other medical device quality system application.
Travel: Some travel required, both domestic and international <20% Must travel internationally and be able to acquire all necessary travel documents
Must be able to complete job responsibilities working with different time zone needs such as attending late night/early morning meetings by phone and/or web to meet global business needs: 15%
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.
OSI Systems, Inc. is a vertically integrated designer and manufacturer of specialized electronic systems and components for critical applications in homeland security, healthcare, defense and aerospace.