About DexcomFounded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.Meet the team:Bring your quality leadership skills to this role, with our Supplier Quality group, to manage multi-site global team and work cross-functionally with supply chain and engineering to ensure suppliers and Contract Manufacturer provide reliable and high-quality components and subassemblies. Summary of the Role:The Director of Supplier Quality contributes to Dexcom's success by leading a transformation and executing a supplier quality strategy in collaboration with the Procurement team, Operations Engineering, R&D, and the manufacturing sites. The right candidate will be a strong leader, strategist, and collaborator with the ability to assess and develop a more effective organization, while championing a strong quality and Medical Device safety culture in all our suppliers. This position is responsible for a wide variety of activities to ensure Dexcom raw materials, sub-assemblies and packaging material suppliers comply with our quality requirements and all applicable regulations, and for developing programs for continuous improvement and prevention of non-conformances.Where you come in:Develop and execute supplier quality strategy in conjunction with procurement and operations engineering.Leading the Global Supplier Quality team by providing expert-level Quality functional leadership, guidance, and direction to your team on the Quality Body-of-Knowledge for supplier controls related to components and materials used in medical devices, drug/device combination products, and purchased finished goods.Organize and manage Medical Device safety and quality audits of raw materials, sub-assemblies, and packaging suppliers for qualification of new suppliers and conduct on-going supplier capability assessments by on-site visits to verify supplier's performance.Successfully engage with cross-functional teams such as R&D, Operations Engineering, Product Development and Procurement, towards selection and management of suppliers.Identifying and leading improvement opportunities to proactively ensure internal and vendor compliance to all applicable internal, domestic, and international quality regulations, including but not limited to US 21 CFR 210, 211, and 820, ISO 13485, ISO 14971, EU MDR, etc.Leading internal supplier quality engineering efforts and partner with our vendors to reduce risk, improve processes, and reduce waste using the quality improvement tools of process control & monitoring, DOE, risk analysis, problem solving processes, protocol development, reporting, trend analysis and reaction, capability analysis and measurement system analysis.Partnering with the Operations and Supply Chain organizations to define and implement effective Supplier Change Management and Supplier Development practices.Developing and maintaining effective Quality Metric performance and identify and execute activities to enhance purchased product quality, reduce supplied material variances, and resolve decreases in performance.What makes you successful:Five (5) years of Supplier Quality, Operations Quality, or Quality Systems Medical Device, Pharmaceutical, or Combination Product experience in a private, public, government or military environmentTen (10) years of quality management experience demonstrating team leadership, compliance excellence, value improvement, and risk reduction.Skills including, but not limited to, Supplier Management, Risk Reduction, Medical Device Manufacturing, Non-conforming Material Control, Continuous Process and Product Improvement, and Organizational LeadershipDemonstrated successful organizational influence in areas including, but not limited to, compliance excellence, continuous improvement, product-related risk mitigation, and/or manufacturing process capability enhancement.Strong verbal and written communication skills with the ability to provide diligent, concise, and fact-based communication to Executive Management, cross-functional peers, and your direct report team.Strong leadership, decision-making, problem-solving, continuous improvement, and management skills with the demonstrated ability to create momentum and deliver results in a timely manner by prioritizing personal workloads, as well as providing guidance, direction, and oversight to others.Understanding and experience in PPAPExperience and Education Requirements:• Typically requires a Bachelor's degree with 15+ years of industry experience• 9+ years of successful management experience in relevant industryPlease note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition ****** you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition ****** the OFCCP's Pay Transparency Non Discrimination Provision at this link . Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=trueTo 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 unsolicitedresumes/applications.Salary:$164,200.00 - $273,600.00
