More jobs:
Quality Engineer
Job in
San Diego, San Diego County, California, 92189, USA
Listed on 2026-09-21
Listing for:
The Fountain Group
Full Time
position Listed on 2026-09-21
Job specializations:
-
Engineering
Quality Engineering, Process Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.
Responsibilities:- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
- Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
- Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Design and conduct experiments for process optimization and/or improvement
- Appropriately document experiment plans and results, including protocol writing and reports
- Lead process control and monitoring of CTQ parameters and specifications
- Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
- Lead the investigation, resolution and prevention of product and process non-conformances
- Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
- Lead in the completion and maintenance of risk analysis
- Work with design engineering in the completion of product verification and validation
- Bachelor’s or Master’s degree in Engineer and minimum of 2 years experience and demonstrated use of Quality tools/methodologies.
- Experience in the medical device industry with detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
- Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- Advanced computer skills, including statistical/data analysis and report writing skills.
- Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
- ASQ CQE or other certifications a plus.
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