Director of Quality Assurance
Job in
Denver, Denver County, Colorado, 80285, USA
Listed on 2026-10-15
Listing for:
Altivera Medical
Full Time
position Listed on 2026-10-15
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Engineering
Job Description & How to Apply Below
- Quality Systems Leadership – Leads, maintains, and continuously improves a compliant and scalable Quality Management System
- Regulatory Compliance – Applies FDA, ISO 13485, design control, CAPA, risk management, validation, and post-market requirements to quality operations
- Audit & Inspection Leadership – Directs readiness and response for FDA inspections, notified body audits, customer audits, and other external assessments
- CAPA & Root Cause Analysis – Drives rigorous investigations, corrective and preventive actions, effectiveness verification, and trend analysis
- Risk-Based Decision Making – Uses quality data, product risk, and regulatory requirements to prioritize issues and guide business decisions
- Team Leadership & Development – Builds, develops, and holds quality teams accountable for strong execution and technical excellence
- Continuous Improvement – Translates quality metrics and operational data into sustainable process and system improvements
- Executive Communication & Collaboration – Communicates quality risks, trends, priorities, and recommendations clearly across leadership and cross-functional teams
- Quality Systems Leadership – Leads, maintains, and continuously improves a compliant and scalable Quality Management System
- Regulatory Compliance – Applies FDA, ISO 13485, design control, CAPA, risk management, validation, and post-market requirements to quality operations
- Audit & Inspection Leadership – Directs readiness and response for FDA inspections, notified body audits, customer audits, and other external assessments
- CAPA & Root Cause Analysis – Drives rigorous investigations, corrective and preventive actions, effectiveness verification, and trend analysis
- Risk-Based Decision Making – Uses quality data, product risk, and regulatory requirements to prioritize issues and guide business decisions
- Team Leadership & Development – Builds, develops, and holds quality teams accountable for strong execution and technical excellence
- Continuous Improvement – Translates quality metrics and operational data into sustainable process and system improvements
- Executive Communication & Collaboration – Communicates quality risks, trends, priorities, and recommendations clearly across leadership and cross-functional teams
- Lead the implementation, maintenance, and continuous improvement of the company’s Quality Management System (QMS)
- Ensure compliance with applicable FDA Quality System requirements, ISO 13485, and other regulatory standards
- Develop and maintain quality policies, procedures, work instructions, quality plans, and documentation controls
- Evaluate QMS effectiveness through metrics, audits, management review, and continuous improvement activities while driving a strong culture of quality
- Serve as the primary quality representative during FDA inspections, notified body audits, customer audits, and other external assessments
- Lead audit preparation, response activities, corrective actions, follow-up commitments, and ongoing inspection readiness
- Ensure quality documentation and records remain complete, compliant, and audit-ready
- Lead investigations involving nonconforming product, complaints, deviations, and quality system issues
- Oversee root cause analysis, CAPA, effectiveness verification, trend analysis, and escalation of significant quality risks
- Establish and monitor key quality performance indicators and use quality and operational data to drive continuous improvement
- Direct risk management activities throughout the product lifecycle
- Oversee design controls, verification and validation,…
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