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 Project and Metrics Specialist identifies, prioritizes and facilitates improvements to software tools and applications used as part of the Spacelabs Global Quality System (Agile, CATSWeb, MFG/Pro, etc). Responsible for generating and maintaining quality system cross-functional metrics. Acts as the quality system software tool owner by identifying and documenting continuous improvement opportunities, prioritizing improvement projects, defining requirements, creating project plans, defining resources required to complete the project, engaging cross functional teams as appropriate, and creating validation criteria for acceptance of the changes prior to implementation.
Acts as business owner for all software tools used as part of the quality system including Agile, CATSWeb, MFG/Pro and ComplianceWire.
Identifies and works cross-functionally to identify continuous improvement opportunities for the tools listed above.
Establishes and maintains validated quality system metrics to include thresholds identified by Functional Managers
Engage cross-functional teams in the coordination, planning and execution of project tasks. Establish objectives, schedule, milestones, assigned tasks and risks with project teams and management, to meet expected deliverables
Establish all QMS and regulatory requirements for projects and ensure they are met.
Develop and publish metrics and project tracking to measure progress and keep project on-track
Assess project risks and works with team members to proactively mitigate them. Work with team members to address project blocking items and escalate to Senior Management as appropriate
Communicates project status to project teams and to upper management.
Thoroughly understands tool function and business processes, and key interactions, inputs and outputs.
Creates validation criteria for acceptance of tool changes prior to implementation
Bachelor’s degree in Quality, engineering, or related field or 4+ years equivalent experience.
Minimum of 4 years of experience working with quality system software tools in a medical device company
3+ years’ experience in managing multiple, complex priorities within demanding timeframes desired. Strong project management skills and methodologies.
Knowledge of FDA and medical device regulatory and registration requirements.
Experience working positively and productively in a team environment. Highly developed relationship-building skills. Highly collaborative.
Ability to deliver results through others, both direct and matrixed.
Excellent communication and negotiation skills, for both internal and external audiences, at all levels.
Knowledge of and ability to work within a global corporate environment is required.
Advanced Microsoft Office user - Powerpoint, Excel, and Word. Experienced with Microsoft Project software.
Must travel internationally and be able to acquire all necessary travel documents.
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 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 companies have a long history of developing innovative solutions to bring a better quality of life to the world. Healthcare, security and defense are among the key markets where we have made significant inroads with new ideas, products and processes. We know that many people live in difficult and dangerous conditions. To improve these circumstances, experts need simple, effective tools... utilizing the latest in technology.
As a global company, we are dedicated to developing these tools for our customers and the people they serve worldwide. Our singular focus is to help security experts, clinical professionals and high-tech developers solve real-world problems and issues. Our OSI Optoelectronics (OSIO) division is a diversified manufacturer of electronic devices and value-added manufacturing services for use in a broad range of applications, including aerospace and defense electronics, security and inspection systems, and medical monitoring and diagnostics.