Overview
Design Quality Engineer Jobs in California, United States at United Consulting Hub
Title: Design Quality Engineer
Company: United Consulting Hub
Location: California, United States
Job Title: Design Quality Engineer
Location: Carlsbad, CA (100% Onsite)
Duration: Contract
Job Summary
We are seeking a Design Quality Engineer to support critical design quality activities for an electromechanical product line within a regulated medical device environment. This role will focus on design change assessments, risk management, CAPA activities, and design validation support. The ideal candidate will work closely with cross-functional teams to ensure product quality, regulatory compliance, and successful implementation of product improvements.
Key Responsibilities:
- Lead and support CAPA investigations, root cause analysis, and corrective action implementation.
- Perform design change assessments and support engineering change order activities.
- Develop, review, and maintain risk management documentation in accordance with quality and regulatory requirements.
- Collaborate with Engineering, Manufacturing, and Quality teams to evaluate product changes and quality impacts.
- Support design verification and validation activities, including protocol and report review.
- Investigate product quality issues and support field failure investigations as needed.
- Author and review technical documentation to support design quality and compliance activities.
- Ensure compliance with applicable quality system regulations and industry standards.
Required Qualifications:
- Bachelor’s degree in Engineering or a related technical discipline.
- Experience leading CAPA investigations and performing root cause analysis.
- Strong background in design change assessments and risk management documentation.
- Experience with electromechanical products in a regulated medical device environment.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work effectively with cross-functional teams.
Preferred Qualifications:
- Experience supporting design validation and verification activities.
- Experience authoring technical reports and quality documentation.
- Knowledge of field failure investigations and post-market quality processes.
- Familiarity with FDA regulations, ISO 13485, and medical device quality systems.
Apply / Refer:
Abhiram
Recruiter | United Consulting Hub
Phone: +1 (469)429-8068
Email: [email protected]
