Manager Quality Compliance

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 were 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 weve 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. Weve already changed millions of lives and were 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. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve 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:

Our Quality organization is at the heart of everything we do. We are a collaborative missiondriven team committed to ensuring that every device we bring to market is safe effective and meets the highest standards of regulatory compliance. As part of the Quality Assurance (QA) Team youll join a diverse group of professionals who work crossfunctionally with Engineering Supply Chain and Operations to uphold our commitment to patient safety and product excellence. We work closely with teams across the company to support design controls validation activities CAPA management supplier quality and product lifecycle initiatives while keeping focus on producing high quality product for our patients. We believe quality is everyones responsibilityand we lead by example.

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 facilitys 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 riskbased methodology that balances patient safety compliance and business needs.

• You can lead root cause analyses with crossfunctional 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 youll 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 Bachelors degree with8-12 years of industry experience

• 2-5 years of previous management or leadexperience

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. Dexcoms AAP may be viewed upon request by contacting Talent Acquisition at

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

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: 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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