Manager Quality Compliance

Dexcom • Mesa, AZ

1d • $111,100 - $185,100

About The Position

The Manager Quality Compliance oversees the site Document Control team and the creation, review, approval, and maintenance of controlled documents within the Quality Management System (QMS). The role ensures compliance with ISO 13485, FDA, and other applicable standards; monitors QMS metrics; drives continuous improvement; and facilitates internal and external audits.

The manager supports regulatory submissions related to complaints, submissions, and change notifications to notified bodies. The role leads cross-functional discussions to identify site needs and maintain alignment with the facility’s approved scope of work and compliance obligations. It also leads remediation of quality-system gaps, observations, and compliance risks, and maintains audit readiness.

The position develops and reports compliance metrics, analyzes quality trends and emerging risks, and presents quality-system performance during management and business reviews. It is responsible for the site Internal Audit program, including risk-based annual and multi-year audit schedules. The manager ensures adherence to internal and external specifications and standards, guides NCMR dispositions, investigations, and CAPAs, and facilitates site-wide Quality, CAPA, and MRB governance forums. The role manages Quality Assurance personnel at varying levels.

The successful candidate applies knowledge of FDA 21 CFR 820 and ISO 13485, technical writing, risk-based analysis, and cross-functional root cause analysis to support compliance, product quality, and patient safety. The position typically requires a bachelor’s degree and 8–12 years of industry experience, including 2–5 years of management or lead experience. Travel required: 5–15%.

Requirements

• Knowledge and understanding of FDA 21 CFR 820 and ISO 13485 Quality Management Systems.
• Ability to organize and prioritize assignments and provide direction to and participate in functional teams.
• Ability to build strong working relationships across organizational levels and champion quality excellence, product quality, and patient safety.
• Technical writing skills for quality and manufacturing documentation and process development, including experience creating and revising technical documentation.
• Ability to work through ambiguity and uncertainty and a proven track record of hands-on work in a fast-paced environment.
• Ability to use analytical tools such as 5 Whys, fishbone, FMEA, and DOE to make defensible decisions using risk-based methodology.
• Ability to lead cross-functional root cause analyses, support high-quality investigations, drive containment and corrective and preventive actions, and ensure timely closure of quality records.
• Leadership ability to influence without authority, coach teams, encourage accountability and integrity, and support employees’ professional development.
• Typically requires a bachelor’s degree and 8–12 years of industry experience.
• 2–5 years of previous management or lead experience.

Nice To Haves

• ASQ certification in Quality Engineering, Reliability Engineering, or Certified Quality Manager/Organizational Excellence.
• Familiarity with experimental design, data analysis, and interpretation of experiments.
• Lean Six Sigma certification.

Responsibilities

• Oversee the site Document Control team and controlled-document creation, review, approval, and maintenance within the QMS.
• Ensure compliance with ISO 13485, FDA, and other applicable regulatory standards.
• Monitor QMS performance metrics and drive continuous improvement initiatives.
• Facilitate internal and external audits.
• Support regulatory submissions related to complaints, submissions, and change notifications to notified bodies.
• Lead cross-functional discussions to identify and address site needs and ensure operations align with the facility’s approved scope of work and compliance obligations.
• Lead remediation activities for quality-system gaps, observations, and compliance risks, and maintain audit readiness.
• Develop and report compliance metrics to site leadership, analyze quality trends, identify emerging compliance risks, and present quality-system performance during management and business reviews.
• Manage the site Internal Audit program, including annual and multi-year audit schedules based on regulatory requirements, risk assessments, prior findings, and QMS performance.
• Ensure compliance with in-house and external specifications and standards.
• Provide guidance on NCMR dispositions, investigations, and CAPAs.
• Develop, manage, and facilitate site-wide Quality, CAPA, and MRB governance forums to support escalation, investigation, documentation, and resolution of quality issues.
• Manage a team of Quality Assurance personnel of varying levels.

Benefits

• Full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Career development through in-house learning programs and/or qualified tuition reimbursement.

What This Job Offers

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