Senior Design Quality Engineer
Caris Life Sciences
5 hours ago
On-site
Phoenix, AZ
Operations
Position Summary
The Senior Design Quality Engineer supports Design Controls, risk management activities, and maintains the Design History File (DHF) to ensure compliance with applicable regulations. Partners with assay development, laboratory operations, regulatory affairs, and quality teams throughout the product lifecycle.
Job Responsibilities
- Create and maintain the Design and Development Plan (DDP) for new development projects throughout the product lifecycle.
- Create and maintain the risk management file (risk management plan/report, hazard analysis, dFMEA, uFMEA).
- Provide mentorship, guidance, and training on design controls and risk management processes.
- Review and approve DHF deliverables (V&V Plan/Protocol/Reports, requirements, specifications).
- Manage deviations and issues for verification and validation activities.
- Support design reviews and design transfer activities (process validations, pFMEA, DMR).
- Support design changes and post-market activities (change controls, CAPA) to ensure product safety.
- Perform risk assessments for regulatory submissions.
- Participate in process improvement initiatives (gap analysis, risk communication).
- May work on special projects related to Design Controls.
Required Qualifications
- Bachelor’s degree in engineering, scientific, or related field.
- 4+ years of hands-on experience (or relevant comparable background).
- Ability to prepare and understand technical documentation (technical reports; V&V protocols/reports).
- Working knowledge of design controls, risk management, and product development processes.
- Experience with ISO 13485, CFR Part 820, ISO 14971.
- Proficiency with U.S. and International medical device regulations and implementing Quality Systems.
Preferred Qualifications
- ISO 15189, CAP/CLIA, and GCP/GCLP.
- Adaptable to fast-paced, dynamic environments.
- Experience with eQMS.
- Experience supporting regulatory inspections.
The Senior Design Quality Engineer supports Design Controls, risk management activities, and maintains the Design History File (DHF) to ensure compliance with applicable regulations. Partners with assay development, laboratory operations, regulatory affairs, and quality teams throughout the product lifecycle.
Job Responsibilities
- Create and maintain the Design and Development Plan (DDP) for new development projects throughout the product lifecycle.
- Create and maintain the risk management file (risk management plan/report, hazard analysis, dFMEA, uFMEA).
- Provide mentorship, guidance, and training on design controls and risk management processes.
- Review and approve DHF deliverables (V&V Plan/Protocol/Reports, requirements, specifications).
- Manage deviations and issues for verification and validation activities.
- Support design reviews and design transfer activities (process validations, pFMEA, DMR).
- Support design changes and post-market activities (change controls, CAPA) to ensure product safety.
- Perform risk assessments for regulatory submissions.
- Participate in process improvement initiatives (gap analysis, risk communication).
- May work on special projects related to Design Controls.
Required Qualifications
- Bachelor’s degree in engineering, scientific, or related field.
- 4+ years of hands-on experience (or relevant comparable background).
- Ability to prepare and understand technical documentation (technical reports; V&V protocols/reports).
- Working knowledge of design controls, risk management, and product development processes.
- Experience with ISO 13485, CFR Part 820, ISO 14971.
- Proficiency with U.S. and International medical device regulations and implementing Quality Systems.
Preferred Qualifications
- ISO 15189, CAP/CLIA, and GCP/GCLP.
- Adaptable to fast-paced, dynamic environments.
- Experience with eQMS.
- Experience supporting regulatory inspections.