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!
As a key member of the Quality Team, the senior design quality engineer will support quality activities related to the design, development, and reliability of Spacelabs Healthcare products. The DQE provides direction in the areas of Design Control & Risk Management to cross-functional teams responsible for new product development and product design changes.
Contribute to New Product Development projects as a core team member and communicate activities to the Regulatory Affairs and Quality extended team members
Provide effective quality engineering support for new product transitions into commercial production
Ensure clarity and consistency in acceptance criteria and that verification and validation processes used are capable
Provide technical and statistical reliability support to Product Development, Manufacturing, and Quality organizations
Lead major efforts, or phases of projects, to resolve complex technical and Quality-related problems
Support the product development teams in the adoption and use of best practices, Quality tools, and Design Control methodologies
Provide effective support for multiple projects, balancing priorities and resources appropriately to meet both project and management expectations
Responsible for the assessment of technical standards against current DHF, labeling and technical file requirements to characterize gaps
Perform Risk Analysis and Failure Mode and Effects Analysis (FMEA) activities to ensure risks are identified and appropriately addressed
Support Risk Management activities to ensure design and process shortcomings are identified and appropriately addressed
Develop reliability improvements to existing & new designs
Work with other groups to maintain an approved internal Quality System that meets the requirements of QSR 21 CFR Part 820 and ISO 13485
Evaluate quality data and prepare periodic reports
Generate, review, and approve Engineering Change Orders for Design Assurance
Support corrective and preventive action activities related to product development and design change
Bachelor's Degree in Engineering or other similar Technical Discipline; or 4 years related experience
7+ years related Quality Assurance/Quality Engineering/Design Assurance experience
4+ years Medical Device Industry
ASQ Certification(s) a plus, Six Sigma experience highly desirable
Excellent working knowledge of FDA Quality System Regulation 21 CFR Part 820 and ISO13485 required
Excellent verbal communication and technical writing skills
Ability to interface with multiple groups in the organization
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.
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.