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.
Summary:
Supervisor QA Engineering is responsible for overseeing the daily operations of the quality assurance department and supervising QA technicians. This role ensures that all production processes and products comply with internal and external quality standards and regulations. The Supervisor will lead testing, inspection, and validation activities to maintain the highest level of product quality.
Essential Duties and Responsibilities:
- Supervise, mentor, and train QA Engineering Technicians on quality procedures and standards.
- Assign and schedule quality tasks and inspections based on production timelines.
- Provide performance feedback and conduct employee evaluations.
- Ensure compliance with company policies, safety protocols, and regulatory requirements.
- Oversee product inspections, testing, and measurements throughout the production process.
- Review and analyze testing data and quality reports to identify trends or areas for improvement.
- Implement corrective and preventive actions (CAPAs) as needed to address quality issues.
- Perform root cause analysis on product defects or non-conformities and implement corrective actions.
- Identify and recommend process improvements to enhance product quality and operational efficiency.
- Lead continuous improvement projects to optimize testing methods and reduce waste.
- Maintain accurate records of quality inspection results and documentation related to product batches.
- Ensure proper documentation of product deviations and non-conformance reports.
- Prepare regular reports on quality metrics, including failure rates, defect trends, and test results.
- Ensure that all products and processes comply with industry standards, such as ISO, FDA, GMP, or others as applicable.
- Assist with internal and external audits related to quality assurance activities.
- Stay updated with industry regulations and standards to ensure company compliance.
- Collaborate with QA, production, engineering, and supply chain teams to resolve quality issues.
- Communicate quality performance to upper management and participate in meetings to provide updates on quality activities.
- May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO).
- May supervise and administer specific aspects of the quality system.
- Develops systems and performs quality functions that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training.
- Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
- 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.
- Reviews schematics and mechanical drawings.
- Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel).
- Assumes and performs other duties as assigned.
Supervisory Responsibilities:
This position may manage a small group of individuals (QA Engineering Technicians and Inspectors). Administer supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Preferred Qualifications:
- Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems)
- Medical device or regulated industry experience.
Education and/or Experience:
- Bachelor’s degree and minimum 5 years of related experience; or 3 years and a Master’s degree; or a PhD without experience; or equivalent combination of education and experience.
- Medical Device experience preferred.
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.