More jobs:
Quality Engineer
Job in
San Diego, San Diego County, California, 92189, USA
Listed on 2026-03-03
Listing for:
MillenniumSoft, Inc
Full Time
position Listed on 2026-03-03
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
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.
- 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.
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