Where you come in
You will oversee the site Document Control team who are responsible for overseeing the creation, review, approval, and maintenance of controlled documents within the Quality Management System (QMS).
You will be responsible for ensuring compliance with ISO 13485, FDA, and other applicable regulatory standards. You will monitor QMS performance metrics and drive continuous improvement initiatives. You will facilitate internal/external audits within the organization.
You will support regulatory submissions related to complaints, submissions and change notifications to notified body. Lead cross-functional discussions to identify and address site needs, ensuring operations remain aligned with the facility's approved scope of work and compliance obligations.
You will lead remediation activities related to quality system gaps, observations, and compliance risks and ensure a state of audit readiness across all quality system processes.
You will be responsible for developing and reporting compliance metrics to site leadership, analyze quality trends and identify emerging compliance risks. You will present quality system performance during management reviews and business reviews.
You will be responsible for the site Internal Audit program by developing annual and multi-year audit schedules based on regulatory requirements, risk assessments, prior audit findings, and quality system performance.
You will ensure compliance to in-house and external specifications and standards. Provide guidance on NCMR dispositions and investigations and guidance on the CAPAs.
You will develop, manage, and facilitate site-wide Quality, CAPA, and MRB governance forums to ensure the efficient escalation, investigation, documentation, and resolution of quality issues while driving compliance, accountability, and continuous improvement.
You will manage a team of Quality Assurance personnel of varying levels.
What makes you successful
You will have knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality Management Systems).
You will be able to organize and prioritize assignments providing direction to and participation in assigned functional teams.
You are able to foster strong working relationships across all organizational levels to champion quality excellence and ensure product quality and patient safety remain at the forefront of all decisions.
You will have technical writing skills as applied to quality and manufacturing documentation and process development – Experience in creating and revising technical documentation.
You have the ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things with a proven track record of working hands-on in a fast-paced environment.
You can use analytical tools (5 Whys, fishbone, FMEA, DOE) to make clear, defensible decisions using risk‑based methodology that balances patient safety, compliance, and business needs.
You can lead root cause analyses with cross‑functional teams and assist your team with writing high-quality investigations, drive containment, corrective, and preventive actions and ensure timely closure of quality records.
You are a leader who can influence without authority, coach teams through compliance and improvement, encourage accountability and integrity and empower employees to reach their full professional potential.
Optional – Certification from the American Society for Quality (ASQ) for Quality Engineering, Reliability Engineering, or Certified Quality Manager/Organizational Excellence is preferred.
Optional – Familiar with experimental design, data analysis, and interpretation of experiments.
Optional – Lean Six Sigma Certification.
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 8-12 years of industry experience
2-5 years of previous management or lead experience
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.
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Salary
$111,100.00 - $185,100.00
#DexcomUS
