Senior QA Engineer – Materials & Design Quality (Remote)

RXinsider LTD.; Northern, San Diego (KY, CA); Hybrid; USD 129,000 - 214,000; Full time

Benefits offered by this job

Comprehensive benefits program

Global growth opportunities

Career development programs

Innovative, industry-leading culture

Job summary

Dexcom Corporation is seeking a Design Quality Engineer to lead material characterization and risk management across advanced CGM product development. You will drive evidence-based decisions and ensure traceability between material attributes and device performance.

The role requires extensive experience in characterization, analytical chemistry, and formulation science within medical devices, with emphasis on ISO 14971 and regulatory submissions. Hybrid work with a global, innovative team.

Qualifications

• Bachelor’s degree in a technical discipline with 13+ years of related experience, or Master’s with 8+ years (PhD + 5+ years).
• Experience in medical device, pharmaceutical, biotechnology, or combination product development and quality engineering.
• Strong knowledge of ISO 14971 risk management and design controls.

Responsibilities

• Serve as the Design Quality Engineering SME for material characterization and risk management.
• Lead quality oversight of characterization and qualification strategies for raw materials, intermediates, formulations, and finished materials.
• Establish traceability between material attributes, formulation characteristics, manufacturing processes, design inputs, and finished device safety and performance.
• Partner with R&D, Materials Science, Analytical Chemistry, Process Development, Manufacturing, and Regulatory to ensure decisions are supported by evidence and quality principles.
• Drive risk-based decision making through ISO 14971 risk management, ensuring hazards, failure modes, and variability are identified and controlled.
• Provide Design Quality leadership for characterization studies, analytical method assessments, stability programs, material compatibility evaluations, and verification activities.
• Represent Design Quality during design reviews, audits, inspections, and regulatory submissions.

Skills

Material characterization

Analytical chemistry

Formulation development

Material science

ISO 14971

Design Controls

Regulatory submissions

Cross-functional collaboration

Data interpretation

Education

Bachelor's degree in Chemistry, Chemical Engineering, Materials Science, Polymer Science, Biochemistry, Biomedical Engineering, Pharmaceutical Sciences, or related field

MS or PhD preferred

Job description

Dexcom Corporation is seeking a Design Quality Engineer to lead material characterization and risk management across advanced CGM product development. You will drive evidence-based decisions and ensure traceability between material attributes and device performance.

The role requires extensive experience in characterization, analytical chemistry, and formulation science within medical devices, with emphasis on ISO 14971 and regulatory submissions. Hybrid work with a global, innovative team.