Overview
Design Quality Engineer Jobs in Carlsbad, CA at United Consulting Hub
Title: Design Quality Engineer
Company: United Consulting Hub
Location: Carlsbad, CA
Job Title: Design Quality Engineer
Location: Carlsbad,CA (Onsite)
Type: contract
Role Overview
We are seeking a Design Quality Engineer to support critical quality initiatives for an electromechanical medical device product line. This role will focus on design change assessments, risk management documentation, CAPA investigations, and design validation support within a regulated environment.
The ideal candidate will have strong analytical and problem-solving skills, along with experience supporting quality systems and product improvement activities in the medical device industry.
Key Responsibilities
- Support design change assessments and engineering change activities
- Lead CAPA investigations, root cause analysis, and corrective action implementation
- Maintain and update risk management documentation
- Support design validation activities and technical report generation
- Investigate product and field quality issues
- Collaborate with cross-functional Engineering, Quality, and Manufacturing teams
- Ensure compliance with medical device quality and regulatory standards
Required Qualifications
- Experience with:
- CAPA ownership and investigations
- Root cause analysis
- Design change assessments
- Risk management documentation
- Background supporting electromechanical medical device products
- Experience working in regulated medical device environments
- Strong analytical, documentation, and troubleshooting skills
Preferred Skills
- Experience supporting design validation activities
- Technical report writing experience
- Exposure to field failure investigations and quality processes
- Familiarity with FDA and ISO 13485 requirements
