RA/QA Project Manager
United States - 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 Project Manager is responsible for the management and successful execution of assigned cross-functional projects from the concept stage through completion. This person is experienced in managing complex, multidisciplinary projects within a matrix organization, has a track record of on-time project delivery, and is capable of recruiting, coordinating and motivating highly dispersed teams. Key success indicators include: ability to facilitate communications between team members and Senior Management, motivate and coach team members to success, provide detailed planning of tasks, track and report on project status, and escalate issues to Senior Management as appropriate.
- Lead cross-functional teams in the coordination, planning and execution the Medical Device Single Audit Program update, and all quality system tool updates. 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.
- Provide frequent communications and formal project reviews with senior management, program team and others as required.
- 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.
- Ensure contract resources are effectively managed and deliver services and products as promised, and that meet our QMS requirements.
- Manage, evaluate and develop project teams to meet functional deliverables and responsibilities.
- Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork.
- Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct.
- Ensure that team members are trained and evaluated on their knowledge and adherence to the Company’s values, 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 and responsibilities may be modified or assigned in order to meet the needs of the business.
- Bachelor’s degree in Quality, Engineering, or related field or 4+ years equivalent experience
- 3+ years’ experience in managing multiple, complex priorities within demanding timeframes desired. Strong project management skills and methodologies.
- Ability to deliver results through others, both direct and matrixed. Proven ability to build/lead dedicated, passionate teams. Can develop, motivate and hold others accountable.
- 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.
- Knowledge of FDA and medical device regulatory and registration requirements preferred.
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.