Manager Quality Compliance

DexCom • Mesa, AZ

2d • Onsite

About The Position

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: Our Quality organization is at the heart of everything we do. We are a collaborative, mission‑driven 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, you’ll join a diverse group of professionals who work cross‑functionally 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 everyone’s responsibility—and we lead by example.

Requirements

• Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality Management Systems.
• Ability to organize and prioritize assignments providing direction to and participation in assigned functional teams.
• Ability 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.
• Technical writing skills as applied to quality and manufacturing documentation and process development – Experience in creating and revising technical documentation.
• 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.
• 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.
• 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.
• 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.

Nice To Haves

• Certification from the American Society for Quality (ASQ) for Quality Engineering, Reliability Engineering, or Certified Quality Manager/Organizational Excellence is preferred.
• Familiar with experimental design, data analysis, and interpretation of experiments.
• Lean Six Sigma Certification.

Responsibilities

• 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).
• Ensure compliance with ISO 13485, FDA, and other applicable regulatory standards.
• Monitor QMS performance metrics and drive continuous improvement initiatives.
• Facilitate internal/external audits within the organization.
• 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.
• Lead remediation activities related to quality system gaps, observations, and compliance risks and ensure a state of audit readiness across all quality system processes.
• Develop and reporting compliance metrics to site leadership, analyze quality trends and identify emerging compliance risks.
• Present quality system performance during management reviews and business reviews.
• 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.
• Ensure compliance to in-house and external specifications and standards.
• Provide guidance on NCMR dispositions and investigations and guidance on the CAPAs.
• 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.
• Manage a team of Quality Assurance personnel of varying levels.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager