Director Quality Assurance at Dexcom

Mesa, Arizona, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Jan, 26

Salary

332600.0

Posted On

07 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, FDA Compliance, ISO Standards, Operational Quality, Team Leadership, Lean Manufacturing, Six Sigma, Continuous Improvement, Risk Management, Internal Audits, Electro-Mechanical Products, Manufacturing Quality, Quality Management Systems, Communication Skills, Interpersonal Skills

Industry

Medical Equipment Manufacturing

Description

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: Join Dexcom's dynamic Operations Quality team at our Phoenix manufacturing site, where we are passionate about shaping the future of healthcare. As part of a collaborative, innovative group, you'll influence global health outcomes and thrive in a culture of excellence and continuous growth. This is your opportunity to make a meaningful impact by driving top-quality standards and resolving compliance challenges in a fast-paced, regulated environment. The Director of Quality for Mesa Operations will play a key role in driving the company's efforts to resolve compliance challenges and enhance the quality management systems (QMS) across the manufacturing site and operational functions. This position is responsible for ensuring all aspects of the Mesa site operations comply with FDA regulations, ISO standards, and internal quality guidelines. The ideal candidate will have extensive experience in addressing FDA compliance challenges and leading quality initiatives in a dynamic, regulated environment. Where You Come In: You have established Quality Assurance leadership in a manufacturing/ production environment with a strong understanding of applicable regulations, such as but not limited to, the Medical Device Regulations, IVD Regulation, QSR, ISO 13485, ISO 14971, MDSAP, MDDAP, etc. You lead a passionate team focused on operational quality and compliance. You drive the company's efforts to resolve ongoing compliance issues and enhance quality management systems (QMS) across the Phoenix manufacturing site and operational functions. You ensure all aspects of Mesa site operations comply with FDA regulations, ISO standards, and internal quality guidelines. You provide direction on manufacturing quality activities, establishing operational objectives and work plans. You build, develop, and lead a strong team focused on sensor quality and product transfer, collaborating with the San Diego Innovation Center. You create, communicate, and execute strategy for the manufacturing quality team in alignment with Corporate and Divisional strategies. You introduce innovative processes and best practices to improve quality, compliance, and operational efficiency. You support the ongoing development and implementation of a Corporate Quality System and act as a change agent. What Makes You Successful: You have established leadership in Quality Assurance within a manufacturing/production environment, with a strong understanding of Medical Device Regulations, IVD Regulation, QSR, ISO 13485, ISO 14971, MDSAP, MDDAP, etc. You bring extensive experience addressing FDA compliance challenges and leading quality initiatives in dynamic, regulated environments. You have led manufacturing/operational quality teams in complex electro-mechanical capital and high-volume disposable products manufacturing. Your knowledge of Operational Excellence and the Shingo Model is desired. You possess excellent communication and interpersonal skills, collaborating effectively across all levels of the organization. You are skilled in implementing lean manufacturing principles, Six Sigma methodologies, and continuous improvement initiatives. Your proficiency includes leading internal audits, inspections, and risk management processes (FMEA). You are adept at driving alignment between quality systems, operational processes, and overall business strategy. What You'll 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: 5-15% Experience and Education Requirements: Typically requires a Bachelor's degree with 15+ years of industry experience 9+ years of successful management experience in relevant industry Please 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 at talentacquisition@dexcom.com. If 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 at talentacquisition@dexcom.com. 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=true 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. Salary: $199,600.00 - $332,600.00

Responsibilities

The Director of Quality for Mesa Operations is responsible for ensuring compliance with FDA regulations and ISO standards across the manufacturing site. This role involves leading quality initiatives and enhancing quality management systems to resolve compliance challenges.