Senior Design Quality Engineer

Overview

The Senior Design Quality Engineer is primarily responsible for supporting the Design Controls, risk management activities, and maintaining the Design history file (DHF), ensuring compliance with all applicable regulations. This role partners closely with assay development, laboratory operations, regulatory affairs, and quality teams throughout the product lifecycle.

• 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.
• May work on special projects as needed in regard to Design Controls

• 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.

• ISO 15189, CAP/CLIA and GCP/GCLP preferred.
• Adaptable to fast-paced, dynamic work environment with shifting demands.
• Experience working with eQMS.
• Experience in supporting regulatory inspections

• Employee may be required to lift routine office supplies and use standard office equipment.
• Ability to sit for extended periods of time.
• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.
• Travel may be required for up to 10% of the time.

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

• This position requires periodic travel and some evenings, weekends and/or holidays.
• Job may require after-hours response to emergency issues.