Director Of Quality Compliance

The Company

Dexcom Corporation (NASDAQ DXCM; Market Cap $44.3B) 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 nearly 10,000 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:

We are currently looking to hire a Director of Quality Compliance! This role is a critical and key leadership position within our Corporate Quality Systems and Compliance group.

In this global function, you will have keen priorities to:

• Unlock global markets

• Achieve on-time approval for new global facilities

• Maintain all certifications and licenses required to operate and distribute product globally

• Reduce regulatory risk

• Govern an efficient and effective Global QMS

Where you come in:

• Responsible for global Quality Management System and Corporate Training functions and leading the QMS team to ensure compliance with applicable regulations and standards, continuous improvement, and meeting goals and objectives

• Standards and regulations interpretation, integration, and maintenance (21 CFR, MDSAP, MDR, ISO 13485, PMDA, etc.)

• Multi-site change collaboration and change management

• New site integration into quality management system

• Notification of substantial change to regulatory authorities

• Corporate Document Control - QMS and policy level

• External Authority Liaison for QMS

• Global Regulatory / Competent Authority / Notified Body

• Corporate Audit

• Primary QMS SME for Internal and External Corporate Audits

• Review and approval of Change Orders and other QMS related items

• QRA Emergency Support, as needed

• Responsible for the SW Quality Engineering Team in support of Enterprise Systems (eQMS) and ensuring enterprise systems comply with QMS requirements and computer software assurance (CSA), while continuously improving processes and transitioning to new guidance and regulations

• Leads the QMS transition to new or updated global regulations or standards

• Leads the QMS integration of new global sites and Mergers & Acquisitions

• Ensures effective sustaining of global QMS

• Continuously assesses the organization and resources to ensure effective support of business scaling and growth

• Continuously improves quality processes and quality systems with the goal of improving the business, reducing risk, maintaining regulatory compliance

• Establishes annual and long-term strategy, key initiatives and goals for the department

What makes you successful:

• Minimum of 15+ years of quality compliance experience, 8 of which should be managing both direct reports and larger indirect organizations

• Global Medical Device Experience (US, EMEA, Canada, APAC, LATAM)

• Interpretation and application of global regulatory requirements and standards

• Global Quality Management System (QMS) implementation, effectiveness, and continuous improvement

• External Audit front room experience

• Six Sigma certification a plus

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:

• 15-25%

Flex Workplace: Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).

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.

Salary:

$156,400.00 - $260,600.00