Quality Engineer

Company: Katalyst HealthCares & Life Sciences
Location: San Clemente
Posted on: March 20, 2023

Job Description:

Job Description

Responsibilities:

• Gather and initiate main documents of DHF: Design Input, Design Output, Design V&V and Design changes
• Support and/or lead Risk Assessment (Risk Management Plan/Report, HA, UFMEA, DFMEA and PFMEA)
• Support R&D in collecting data of Remediation project
• Initiating testing protocols/reports
• Create and edit Design documents supporting technical Assessment, testing reports and Regulatory submission
• Build productive relationships internally and externally
• Work with R&D, Quality Engineers, and Manufacturing Engineers on qualification of new or modified Design and Process
• Support initiatives for continuous quality improvements Requirements:
  • Bachelor's degree in Engineering or Technology
  • 3-4 years' experience in the Medical Device OR Engineering Industry
  • Design Quality experience required.
  • Would like someone w/ previous design exp. - protocols and reports as well as risk management files.
  • Would like someone with medical device exp. but not required
  • ASQ certification would be preferred but not required
  • Knowledge of the Medical Device Industry and familiarity with ISO and FDA QSR Regulations
  • Proven knowledge in initiating/leading Risk Assessment (Risk Management Plan/Report, HA, UFMEA, DFMEA and PFMEA)
  • Proven knowledge in structuring DHF
  • Preferred knowledge in DOE, Process Capability, Gage R&R, etc.
  • Preferred knowledge in supporting Software development
  • High Technical writing competency
  • Knowledge of the Medical Device Industry and familiarity with ISO and FDA QSR Regulations
  • Proven knowledge in initiating/leading Risk Assessment (Risk Management Plan/Report, HA, UFMEA, DFMEA and PFMEA)
  • Proven knowledge in structuring DHF
  • Preferred knowledge in DOE, Process Capability, Gage R&R, etc.
  • Preferred knowledge in supporting Software development
  • High Technical writing competency

Keywords: Katalyst HealthCares & Life Sciences, San Clemente , Quality Engineer, Engineering , San Clemente, California