Senior Design Quality Engineer

Senior Design Quality Engineer
in US - WA - Snoqualmie

Job Overview

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.

Job Description

  • 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
  • Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork
  • Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct
  • 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

Job Qualifications

  • 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

 

Equal Opportunity Employer

EEO is the Law

Poster Link: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.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.

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