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Sr. Staff Quality Engineer

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MillenniumSoft Inc

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Location:
United States , San Diego

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Category:
Quality Control

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Contract Type:
Contract work

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Salary:

Not provided
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Job Description:

The Sr. Staff Quality Engineer is a contract role responsible for leading a project to enhance the quality and compliance of the Dispensing Implementation process. The role involves collaborating with Dispensing Implementation teams to document processes, identify compliance gaps, and suggest improvements to ensure regulatory compliance that meets external inspection standards.

Job Responsibility:

  • Evaluate the Dispensing Implementation process for compliance with CFR 820.200 and international regulatory standards
  • Lead a cross-functional effort to develop and implement a plan to improve the compliance state of the process
  • Provide weekly status updates to the Quality and SDS leadership teams
  • Ensure compliance with all service record documentation requirements
  • Adhere to Inspire Quality Processes
  • Drive effective and efficient execution of installation and implementation processes

Requirements:

  • Minimum 10 years’ experience in a Quality role within FDA-regulated environments
  • Proven experience in quality requirements for medical device installation
  • Extensive history of completing quality/compliance improvement projects in FDA-regulated environments
  • Strong experience with installation of medical devices, particularly those with embedded software (preferred)
  • Strong knowledge of quality engineering principles, policies, and best practices
  • Proficiency in Quality Engineering tools like Sampling Plans, Root Cause Analysis, and Statistical Analysis
  • Ability to collaborate across functions and teams to drive compliance improvements
  • Excellent verbal communication and interpersonal skills
  • Strong organizational skills, attention to detail, and ability to multi-task efficiently
  • Proficiency in Microsoft Excel, Word, and other business systems
  • Bachelor's degree in a relevant engineering field
  • Quality Engineering Certification (ASQ) or equivalent (preferred)
  • Demonstrated ability to work independently and proactively
  • Ability to act as a resource for colleagues with less experience and mentor them effectively

Nice to have:

  • Strong experience with installation of medical devices, particularly those with embedded software
  • Quality Engineering Certification (ASQ) or equivalent

Additional Information:

Job Posted:
January 11, 2026

Employment Type:
Fulltime
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