Overview:
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!
At Spacelabs Healthcare, you make a difference.
Every member of our worldwide team is integral in improving treatment and helping providers deliver exceptional care to their patients. From newborns to centenarians, more than 60 million people benefit yearly from the advancements we make in patient monitoring and management, care coordination, and clinical decision support.
Driven by the belief that anyone who seeks care could be a member of our own family, our team is dedicated to solving the greatest challenges the healthcare system currently faces, including the need to enhance the patient experience, improve population health, reduce costs, support care team well-being, and advance health equity. As part of our mission, we take pride in creating services and technologies that are personalized and tailored to support the needs of healthcare providers anywhere in the world.
While we may not be at a patient’s bedside, their health is still in our hands
The Sr. Quality Assurance Engineer (Cloud Systems) shall provide leadership and support for QMS performance in many facets of business operations:

KNOW YOUR RIGHTS

Poster Link:
https://www.eeoc.gov/sites/default/files/2023-06/22-088EEOCKnowYourRights6.12ScreenRdr.pdf
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

• Ensure high quality of products and services, by implementing and maintaining the Quality Management System.
• Ensure that QMS activities are risk-based.
• Perform, report, and drive remediation from Internal Quality Audits and participate in third party audit and inspection activities (MDR, MDSAP, etc.).
• Routinely pursue more efficient and effective operations (continual improvement).
• Support the development teams of all business areas, working within the project teams on new or sustaining product development projects.
• Support the maintenance of the Essential Requirements Checklists / General Safety, Essential Requirements checklist and Technical Documentation Files.
• Assist with the compliance to changes to standards such as EN 60601-1, ROHS3, REACH, and Global regulatory requirements applicable to Spacelabs’ products.
• Provide Quality System guidance to his or her product design teams. He or she shall be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records.
• Collaborate with engineering to determine and execute engineering design and development planning in support of regulatory submissions.
• Review Engineering Change Requests and Engineering Change Orders to identify critical components, defects in drawings/schematics, effective and adequate design documentation, product safety, and Quality System compliance.
• Assist with the creation, maintenance, and performance of QMS change management tools: Corrective Action Reports (CAR’s), Preventive Action Reports (PAR’s), and Process Change Orders (PCO’s).
• Support the manufacturing teams of all business areas, working within the teams on new or sustaining product and process improvements.
• Support the establishment of product cloud systems and configuration management.
• Shall review and approve Device History Record (DHR) deliverables to ensure that production activities comply with Mandatory Device Master Record (DMR) requirements.
• Perform Manufacturing floor walkthroughs based on 7S criteria to support improvements and collaboration.
• Facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders.
• Create and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP.
• Assist in the preparation and submittal of registration applications. May assist in the preparation of IDE, 510(k), CE Mark, and other similar regulatory filings.
• Shall participate in cross-functional design teams to review all Design and Development Plans, Design Inputs, Design Outputs, V&V documents, and Design Changes including Defect Reports. Senior Quality Assurance Engineers shall recognize potential impacts to health or device efficacy (“Safety Issues”), support criticality assessment needed to ensure the application of reasonable and required Risk Management, Verification and Validation, and adequate record-keeping practices.
• Upholds the Company’s core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrates behavior consistent with the Company’s Code of Ethics and Conduct. Ensure that direct report(s) 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 for corrective action to be implemented and to avoid the recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business