Sr Quality Compliance Specialist

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.

About Dexcom

Our Quality Assurance team are looking for a dynamic and skilled Senior Quality Compliance Specialist (onsite role) to support the start-up of our first European manufacturing site in Athenry.

Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes.

Functional Description

Assists and supports the organization in complying with, as well as the ongoing preparation, testing and monitoring of conformance to, the requirements of government regulations and/or regulatory agencies. Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes. Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external

audits and inspections. May serve as point of contact for interactions with regulatory agencies for defined matters.

Essential Duties and Responsibilities

• Lead Quality and Compliance Activities: Oversee the quality and compliance aspects of establishing and maintaining processes related to commercial product shipment and release from Dexcom Ireland and global distribution centres.
• Own and Manage Quality Plans: Develop, implement, and maintain Quality Plans that ensure Dexcom’s medical devices meet regulatory, customer, and internal quality requirements throughout the product lifecycle.
• Change Management Leadership: Own and manage change orders impacting the Quality Management System (QMS). Facilitate cross-functional collaboration across departments and sites to ensure changes are thoroughly assessed and effectively implemented.
• CAPA and Process Improvement: Lead Corrective and Preventive Action (CAPA) investigations and drive process improvement initiatives related to the QMS. Ensure timely resolution and effectiveness verification.
• Quality Documentation Oversight: Provide guidance and support in assessing changes to QMS documentation, ensuring compliance with applicable standards and regulations.
• Regulatory Integration and Gap Assessments: Lead or support the integration of new regulations or QMS standards by conducting gap assessments, recommending updates, and driving documentation revisions.
• Continuous Improvement of QMS: Champion ongoing improvement and maintenance of the QMS to enhance operational efficiency, compliance, and product quality.
• Audit and Inspection Readiness: Conduct internal audits and support external inspections by regulatory bodies and notified parties. Ensure audit findings are addressed and closed effectively.
• Other Duties as Assigned: This job description reflects management’s assignment of essential functions and does not restrict additional responsibilities that may be delegated.

Required Educational Requirements and Experience:

• Typically requires a Bachelor’s degree, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years’ experience. 
• Direct experience with Quality Management Systems, Audits, CAPA, Management Review
• Knowledgeable in ISO 13485:2016, CFR Part 820, ISO 14971, CMDR and other regulations applicable to Medical Devices.
• Collaborative, able to work effectively with diverse functional groups, able to multitask and adjust to change in priorities
• To perform this job successfully, an individual must value and demonstrate diligence for compliance, as well as demonstrate technical competence and good judgement associated with each essential duty and responsibility.

Functional/Business Knowledge:

• A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
• Demonstrates further technical development and a track record of project success
• Demonstrates an ability to coordinate multiple projects simultaneously
• Considered a specialist in the field within the function.

Scope:

• Assists in determining objectives of assignment. Plan schedules and arranges own activities in accomplishing objectives.
•  Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Networks with senior internal and external colleagues in own area of expertise.

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 organisation committed to our employees, customers, and the communities we serve.

Travel Required

0-5%

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.

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.