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:

You will join Dexcom’s Quality team, a dynamic group dedicated to ensuring the integrity and compliance of our products throughout the distribution chain. You will play a key role in safeguarding product quality and patient safety across India’s rapidly evolving healthcare landscape as well as support global distributor and wholesaler quality. This position is responsible for overall quality and quality compliance for Dexcom India. This includes, but not limited to, QMS systems, QC inspections, warehouse and third-party logistics operations affiliated with Dexcom India.

Where you come in:

• You will be responsible for effective implementation of QMS for Dexcom India. Ensuring ongoing compliance to local regulations for all products marketed by Dexcom India. This includes the ownership of QMS, GQP and GMP responsibilities for all product categories being commercially distributed/sold in the Indian market.
• You will manage distributor and wholesaler quality agreements globally and verify compliance with Dexcom requirements
• You will be required to keep country management aware of quality related issues through periodic Management Review process and issue escalation
• You will be responsible for escalation of relevant quality related issues within the region to Dexcom Corporate (Quality Assurance and Quality Compliance), facilitating the non-conformance and CAPA processes, ensuring compliance with customer complaint process where needed, and all quality assurance and quality compliance components of the QMS in India
• You will be responsible for regulatory inspections/audits, including issue resolutions with government authorities and company management
• You will assess risk and support quality activities for distribution and logistics partners
• You will be responsible for conducting audits
• You will oversee temperature excursion investigations, complaints, and recall coordination, ensuring timely and effective resolution
• You will actively partner with various functions within India, Asia Pacific, and Dexcom Corporate Headquarters USA to meet business objectives
• Accountabilities also include working with Regulatory Affairs as required to ensure regulatory compliance
• Position will be accountable for effective and efficient communications with all relevant partners within Dexcom, as well as fostering a culture of quality for all employees.

What makes you successful:

• Strong knowledge of ISO 13485, WHO GDP, CDSCO GDP/India Medical Device Rules (MDR 2017)
• You are skilled in audits and QMS administration with a track record of driving continuous improvement
• You bring analytical and problem-solving skills for issue management and root cause analysis
• You can influence external partners and internal stakeholders to achieve quality objectives
• You demonstrate attention to detail, organisational skills, and the ability to manage multiple priorities in a fast-paced environment.

What you will get:

• 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.

Travel Required:

• 25 to 50%

Education and Experience:  

• Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of related 

experience

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.