Senior Quality Engineer — Validation & Regulatory Leader

RXinsider LTD.; San Diego, Northern (CA, KY); Hybrid; USD 87,000 - 145,000; Full time

Benefits offered by this job

Benefits program

Career development

Global opportunities

Tuition reimbursement

Job summary

Dexcom Corporation, a global leader in CGM, seeks a senior quality leader to drive complex investigations, CAPAs, and NCMRs across sites. You will own validation strategies, partner with R&D, Regulatory, Manufacturing, and global teams, and guide design transfer from development to high-volume manufacturing.

Strong ownership and communication are essential. The role requires a technical degree and extensive experience in risk management, Six Sigma, and data-driven decision making.

Qualifications

• Bachelor's degree in a technical discipline; 5–8 years experience or Master’s with 2–5 years; PhD with 0–2 years.
• Advanced quality engineering knowledge including risk management, RCA, Six Sigma, CpK/PpK, statistical analysis, sampling plans, AQL, and data-driven decision-making.
• Experience developing and executing validation strategies including IQ/OQ/PQ/PV, test method validation, software V&V, and process validation.
• Proficiency in design transfer and commercialization, applying risk-based decisions to transition new products from development to high-volume manufacturing.
• Strong ownership, cross-functional leadership, and ability to communicate with senior leadership.
• Ability to collaborate with Manufacturing, R&D, Regulatory Affairs, and global teams.

Responsibilities

• Lead complex quality investigations by driving root cause analysis, CAPAs, NCMRs (MRB/disposition), and systemic corrective actions.
• Provide technical leadership in quality engineering and continuous improvement methodologies (Six Sigma, Lean, Gage R&R, sampling, risk-based problem solving).
• Drive Quality Management System excellence through procedures, controls, validations, FMEAs, and quality processes.
• Own validation and qualification strategies for equipment, processes, test methods, and software V&V.
• Serve as quality engineering lead on cross-functional projects with R&D, Regulatory Affairs, Manufacturing, Operations, and global teams.
• Guide design transfer and commercialization to scale from development to high-volume manufacturing.
• Assess and mitigate risk by influencing design decisions and implementing robust controls.
• Identify and close compliance gaps by addressing quality system weaknesses and CAPAs.
• Communicate complex topics effectively across organizational levels and with senior leadership.
• Represent Quality during internal audits and regulatory inspections.

Skills

Root cause analysis

CAPA management

NCMRs

Six Sigma

Process capability

QA leadership

Data analysis

Education

Bachelor's in Chemical Engineering

Tools

JMP

Excel

Job description

Dexcom Corporation, a global leader in CGM, seeks a senior quality leader to drive complex investigations, CAPAs, and NCMRs across sites. You will own validation strategies, partner with R&D, Regulatory, Manufacturing, and global teams, and guide design transfer from development to high-volume manufacturing.

Strong ownership and communication are essential. The role requires a technical degree and extensive experience in risk management, Six Sigma, and data-driven decision making.