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
Performs supervisory and administrative duties associated with product Lot Release personnel management.
Coordinates the tasks and work plans of the product release inspections.
Ensure that all quality control activities comply with applicable regulatory requirements.
Essential Duties and Responsibilities
This list contains tasks that are typically associated with the job. It is not all-inclusive and Dexcom may, depending on the specific nature of the position, modify these tasks and/or identify additional tasks, based on business needs.
* Build and lead a team of quality inspectors to perform thorough inspections of final products before shipment. This team will also be responsible for reviewing Lot Release paperwork and data at a sub assembly and finished goods level.
* Lead the set up/ establishment of the Lot Release test lab in the Athenry facility
* Oversee day-to-day operations of our Lot Release lab
* Implement and manage in-process quality control procedures to monitor and evaluate production processes.
* Collaborate with production teams to identify and address quality issues in real time.
* Support in routine audit readiness activities including cconduct regular Gemba walk, inspections and audits to ensure compliance with quality standards.
* Maintain accurate and detailed records of in-process and outgoing quality control activities.
* Prepare and submit comprehensive quality reports to management, highlighting key performance indicators, trends, and areas for improvement.
* Participate in root cause analysis and corrective action initiatives.
* Provide training to production and quality control personnel on quality standards, procedures, and best practices.
* Foster a culture of continuous improvement and quality consciousness throughout the organization.
* Responsible for addressing people performance issues and conflict resolutions if they arise
* Ensure a culture within production where Safety and Quality are a priority
* Focus on development of the individuals on the team for the benefit of the individual and Dexcom.
* Responsible for addressing people performance issues and conflict resolutions if they arise
* Ensure a culture within production where Safety and Quality are a priority
* Focus on development of the individuals on the team for the benefit of the individual and Dexcom.
* Stay updated on relevant industry regulations and standards.
* 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/ Experience
* Minimum a Bachelor's degree with 5 years of medical device, pharmaceutical, or other regulated industry experience in a supervisory role.Strong understanding of quality management systems, regulations, and standards (e.g., ISO
* Experience with statistical tools and methods for quality control
* Experience with start-up & scale-up organizations an advantage
* Experience working in a Digital Factory
* Proficiency with Microsoft Office, ERP System
* Strong problem solving and data analysis skill.
* Excellent leadership and communication skills.
* Ability to work collaboratively across cross-functional teams.
* Ability to work hands-on in a fast-paced environment
* Detail-oriented with a focus on continuous improvement.
What you'll get
* A front row seat to life changing CGM technology.
* 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.
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.