Sr QA Engineer- CAPA

Dexcom•San Diego, CA

3d•$87,000 - $145,000•Remote

About The Position

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: As a Sr QA Engineer your role will be responsible for executing and coordinating Corrective and Preventive Actions (CAPA), Health Hazard Assessments (HHA/HHE), Non-Conforming Events (NCE), support Internal and External Audits, defining requirements and aiding in the development of analytic dashboards, validating, and deploying Quality Assurance data and information dashboards with focus on Manufacturing Controls, Quality Management Systems and New Product Development. This position will interface with different cross functional groups (Operations Data Analytics, Customer Advocacy, Quality Engineering, Software Engineering, Software Test, Regulatory Affairs, and others). The Sr. Quality Engineer role provides Quality Assurance Engineering and Compliance expertise, and technical support to Sustaining Quality Engineering and Quality Control teams to ensure they have the necessary information to make quality decisions, facilitate compliance to Dexcom's Quality Management System and international regulation standards (e.g. 21 CFR Part 11, 801, 803, 820; ISO 13485, ISO 14971).

Requirements

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.
Typically requires a Bachelor's degree in a technical discipline, and a minimum of 5-8 years related experience or Master's degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.

Nice To Haves

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
Certified Quality Engineer, Certified Quality Auditor a plus.

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.
Guides and maintains the CAPA process, including investigation, root cause analysis, corrective and preventive actions, and effectiveness verification, to drive continuous improvement and prevent recurrence of quality issues.
Ensure CAPA activities are completed thoroughly, timely, and with objective evidence.
Facilitate and guide investigations follow rigorous, science‑based methodologies (e.g., 5 Why, Fishbone, Fault Tree Analysis, DMAIC).
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.
Applies risk management, validation, sample size, and external standards review and implementation activities.
Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
Assumes and performs other duties as assigned.

Benefits

A front row seat to life changing CGM technology.
Learn about our brave #dexcomwarriors community.
A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.
An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

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