What are the responsibilities and job description for the Design Quality Engineer position at United Pharma?
Role :Design Quality Engineer
Location: Carlsbad, CA (100% Onsite)
Duration :12 months
Contract :W2
Experience :0-5 years
Position Overview
We are seeking an experienced Design Quality Engineer to support critical quality initiatives for a regulated electromechanical product portfolio. This role will play a key part in ensuring product quality throughout the design lifecycle by leading design change assessments, supporting risk management activities, and contributing to design validation efforts associated with product enhancements and sustaining engineering projects.
The ideal candidate will collaborate closely with engineering, manufacturing, regulatory, and quality teams to manage engineering change orders, investigate product quality issues, and drive corrective and preventive actions (CAPAs). Success in this role requires strong analytical thinking, hands-on problem-solving capabilities, and a solid understanding of quality systems within a medical device or similarly regulated environment.
Key Responsibilities
- Lead and support design change assessments to evaluate product modifications and their impact on quality, safety, and regulatory compliance.
- Own and drive CAPA investigations, including root cause analysis, corrective action implementation, and effectiveness verification.
- Support risk management activities, including risk assessments, hazard analysis, and maintenance of risk documentation.
- Collaborate with cross-functional teams to manage engineering change orders and product improvement initiatives.
- Participate in design validation activities and ensure compliance with applicable quality and regulatory requirements.
- Investigate product quality issues, nonconformances, and field performance concerns.
- Generate and maintain quality documentation to support product development and sustaining engineering efforts.
- Contribute to continuous improvement initiatives that enhance product quality and process effectiveness.
Required Qualifications
- Proven experience owning and managing CAPA investigations, root cause analysis, and corrective action implementation.
- Strong background in design change assessments and risk management documentation.
- Experience supporting electromechanical products within a regulated environment, preferably medical devices.
- Working knowledge of quality systems, design controls, and regulatory compliance requirements.
- Excellent analytical, troubleshooting, and cross-functional collaboration skills.
Preferred Qualifications
- Experience supporting design verification and validation (V&V) activities and authoring technical reports.
- Exposure to field failure investigations, complaint handling, and post-market quality processes.
- Familiarity with medical device regulations, quality standards, and design control requirements.
- Experience working in a fast-paced product development or sustaining engineering environment.