Quality Assurance Manager

The Company

Dexcom Corporation (NASDAQ DXCM; Market Cap $44.3B) 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 nearly 10,000 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

The Quality Assurance (QA) Manager is responsible for overseeing the quality assurance and control activities within the manufacturing operations. This role ensures that products are manufactured according to quality standards and regulatory requirements, with a focus on continuous improvement, process validation, and defect reduction.

Essential Duties and Responsibilities

• Lead and manage the quality assurance (QA) team to ensure effective quality assurance processes within operations
• Assures smooth operating of the inspection unit maintaining daily records and reports
• Prioritizes schedules based on product introduction and manufacturing schedules maintaining a minimum turnaround time
• Establish and maintain quality control procedures and inspection processes
• Ensure compliance with relevant regulatory requirements, such as FDA, ISO 13485, and other applicable standards
• Prepare for and participate in internal and external audits, addressing any findings and implementing corrective actions
• Outlines and implements training procedures of employees for the inspection operation including drawings prints schematics and quality assurance standards
• Lead continuous improvement initiatives and implement corrective actions
• Conduct risk assessments to identify potential quality issues and develop mitigation plans
• Plan and allocate resources effectively to meet quality objectives
• Monitor expenditures to ensure alignment with the budget and financial objectives
• Works with QA, Manufacturing, Engineering, Supply chain and other department personnel, as necessary, to support quality and business objectives
• Assumes and performs other duties as assigned

Required Qualifications

• Minimum Bachelor’s degree in science, Engineering, or a related field
• Minimum of 5-7 years of experience in quality assurance, preferably in the medical device or pharmaceutical industry
• In-depth knowledge of ISO 13485, FDA regulations and other relevant standards
• Strong leadership and team management skills
• Excellent analytical and problem-solving abilities
• Effective communication skills, both written and verbal
• Detail-oriented with a focus on continuous improvement
• Ability to work collaboratively across cross-functional teams
• Ability to work hands-on in a fast-paced environment

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.