Director of Quality - Manufacturing Operations

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:

As the Director of Quality for Operations, you will lead a passionate team, drive top-quality standards, and shape the future of healthcare. The Director of Quality for Operations Quality will play a key role in driving the company’s efforts to resolve ongoing compliance issues and enhance the quality management systems (QMS) across San Diego manufacturing site and operational functions.

This position is responsible for ensuring all aspects of the San Diego site operations comply with FDA regulations, ISO standards, and internal quality guidelines. Come and collaborate with innovative minds, influence global health outcomes, and thrive in a culture of excellence and continuous growth.

The ideal candidate will have extensive experience in addressing FDA compliance risks and leading quality initiatives in a dynamic, regulated and fast-paced environment.

Where you come in:

• You will be responsible for activities related to the current good manufacturing processes (cGMP and assuring smooth operations of the San Diego manufacturing quality processes.

• You will provide direction on overall performance of manufacturing quality activities establishing operational objectives and work plans.

• Build, develop and lead a strong team focused on sensor quality and transfer of design from R&D to Manufacturing.

• Create, communicate and execute strategy for manufacturing quality team in alignment with Corporate and Divisional strategies

• Introduce innovative processes and best practices to improve quality and compliance and deliver efficiencies in collaboration with operations, site quality partners.

• Support the ongoing development and implementation of a Corporate Quality System and act as a change agent.

FDA Compliance & Corrective Action Leadership:

• Lead the company’s response to the FDA’s compliance challenges, including developing and implementing corrective and preventive actions (CAPA) to address FDA observations and non-compliance issues.

• Work closely with regulatory affairs and senior leadership to ensure effective remediation of FDA findings, tracking progress, and ensuring corrective actions are sustained.

• Lead the company through FDA inspections, ensuring readiness and positive outcomes, and facilitating transparent communication with regulatory authorities.

Operations Quality Management:

• Oversee the operations quality management system, ensuring full compliance with FDA 21 CFR Part 820, ISO 13485, and other relevant regulatory standards.

• Manage and improve manufacturing quality control processes, product release protocols, and non-conformance management to ensure high standards are maintained.

• Lead the implementation of effective risk management processes, including FMEA (Failure Modes and Effects Analysis), to identify and mitigate operational risks.

Cross-Functional Leadership:

• Partner with Manufacturing, Engineering, Regulatory Affairs, and Senior Leadership teams to ensure alignment on quality goals, regulatory compliance initiatives, and operational improvements.

• Provide leadership and mentorship to the quality team, fostering a culture of quality, continuous improvement, and compliance.

• Drive alignment between quality systems, operational processes, and the overall business strategy to ensure seamless and efficient manufacturing operations.

Quality System Enhancement & Continuous Improvement:

• Identify areas for process improvement in manufacturing and operational workflows, implementing lean manufacturing principles, Six Sigma methodologies, or other continuous improvement initiatives.

• Lead and oversee internal audits and inspections to ensure adherence to quality standards and regulatory requirements.

• Drive initiatives to improve the company’s QMS, ensuring that all quality documents, training programs, and operational processes align with regulatory expectations.

What makes you successful:

• 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.

• Experience leading manufacturing / operational quality teams in complex electro-mechanical capital and high-volume disposable products manufacturing environment.

• Knowledge of Operational Excellence and Shingo Model desired

• Excellent communication and interpersonal skills, with the ability to collaborate effectively across all levels of the organization.

• BS Degree in Engineering or related technical degree (Industrial or Mechanical Engineering preferred), Master’s degree preferred.

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.

Education and Experience:

• Typically requires a Bachelor’s degree with 15+ years of industry experience

• 9+ years of successful management experience in relevant industry

Travel Required:

• 10%

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. 

View 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=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.
 

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