QA Specialist responsible for monitoring VIP and Sales team interactions ensuring compliance and quality standards. Supporting Customer Service QA activities and delivering targeted training sessions.
About the role
- Senior Design Quality Engineer at Caris responsible for design controls and risk management. Collaborating with teams to maintain compliance and ensure product safety throughout the development lifecycle.
Responsibilities
- Responsible for creating the Design and Development Plan (DDP) for the new development projects, updating the DDP throughout the lifecycle of the product.
- Create and maintain risk management file with support from cross-functional teams including risk management plan/report, hazard analysis, dFMEA, uFMEA.
- Provide mentorship, guidance and training to the product development teams new to design controls and risk management processes.
- Review and approve DHF deliverables including V&V Plan/Protocol/Reports, requirements, and specifications.
- Manage deviation and issues for the verification and validation activities.
- Support design reviews and design transfer activities including process validations, pFMEA and DMR.
- Support design changes and post market activities, for example change controls and corrective and preventive actions (CAPA) to ensure product safety.
- Perform risk assessments for the regulatory submissions.
- Participate in process improvement initiatives as necessary, performing gap analysis and risk communication.
Requirements
- Bachelor’s degree in engineering, scientific or related field.
- Minimum 4+ years of hands-on experience, or relevant comparable background.
- The ability to prepare and understand technical documentation such as technical reports, verification and validation protocols and reports.
- Working knowledge of design controls, risk management and product development processes.
- Experience with ISO 13485, CFR Part 820, ISO 14971.
- Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems.
- Adaptable to fast-paced, dynamic work environment with shifting demands.
- Experience working with eQMS.
- Experience in supporting regulatory inspections.
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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