Quality Engineer 3

MillenniumSoft, Inc

• $100K — $130K *
San Diego, CA 92154In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
More than 3 months ago
Job Overview by Ladders

Qualifications

  • 10+ years in a Quality role in FDA-regulated environments
  • Experience in medical device installation quality requirements
  • History of completing compliance improvement projects
  • Strong installation experience with medical devices, especially those with embedded software
  • Bachelor's degree in relevant engineering field
  • Quality Engineering Certification (ASQ) preferred
  • Ability to mentor less experienced colleagues

Responsibilities

  • Evaluate compliance of Dispensing Implementation process with FDA regulations
  • Lead cross-functional efforts to enhance compliance processes
  • Provide weekly updates to leadership on project status
  • Ensure compliance with documentation requirements
  • Adhere to Inspire Quality Processes standards
  • Drive efficiency in installation and implementation tasks

Benefits

  • Collaborative work environment
  • Opportunities for career advancement
  • Continuous learning and development programs
  • Support for professional certification growth
Full Job Description
Roles & Responsibilities

  • 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.


Experience Required

  • 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).


Skills & Certifications

  • 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.


Eligibilities & qualifications

  • 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.
* Ladders Estimates

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