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Dexcom Deutschland GmbH · 2 days ago

Sr QA Engineer

San Diego, CA

Full-time

Onsite

Mid, Senior Level

$87K/yr - $145K/yr

5+ years exp

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). As a Sr QA Engineer, you will be responsible for executing and coordinating quality assurance processes, ensuring compliance with regulatory standards, and supporting cross-functional teams in quality management efforts.

Medical Device

Responsibilities

Leads and Coordinates and ensures compliance to CAPA, HHA and NCE systems. Provide guidance as necessary to ensure appropriate depth of investigation and corrective and/or preventive actions. Assess effectiveness of corrective and preventive actions. Prepare QA Review Board meetings agenda and minutes

Aid in the design, development, validation, and deployment of Quality Assurance Metric Dashboards for all areas of Operations Quality Assurance in San Diego

QA Continuous Improvement Projects

May administer specific aspects of the quality system

Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include Equipment, Process, Software and Test Method Validation, Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training

Participates in internal audits, supplier audits to ensure systems comply with requirements and are effective

Participates as member of the design team. Activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs

Applies risk management, validation, sample size, and external standards review and implementation activities

Coordinates the disposition of nonconforming materials with the Materials Review Board

Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools

Qualification

Quality Management SystemsCAPAFDA auditsStatistical analysisOraclePower BICertified Quality EngineerCollaborationProblem solvingPositive attitude

Required

Direct experience with Quality Management Systems, Nonconforming Material, CAPA, HHA/HHE, Nonconforming Events, Internal and External Audits

Experience in FDA audits

Good understanding of QMS as applied to medical devices

Collaborative, able to work effectively and lead diverse functional groups

Demonstrates good judgment in selecting methods and techniques for problem solving and obtaining solutions

Can work well alone, normally receives little instruction on day-to-day work, general instructions on new assignments

A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities

Experience with Oracle, Camstar, IQVIA, 1Factory, EtQ Reliance, Korber, SQL Servers, Power BI, Tableau

Experience with statistical analysis and statistical analysis software packages like Minitab and Jump

Typically requires a Bachelors degree in a technical discipline with 5-8 years of related industry experience or a Masters Degree and 2-5 years of equivalent industry experience or a PhD and 0-2 years of experience