Confidential Jobs · 4 days ago
Vice President Quality Assurance
Denver, CO
Full-time
Onsite
Director/Executive
$250K/yr - $325K/yr
15+ years expConfidential Jobs is a privately held, commercial-stage medical device company seeking a Vice President of Device Quality Assurance to lead and evolve its Quality function during a period of operational growth and product expansion. This senior leadership role involves setting Quality strategy and ensuring compliance, product quality, and audit readiness across a portfolio of FDA-cleared medical devices.
Computer Software
Responsibilities
Provide executive leadership for the Device Quality organization, including QA and QC teams
Own and continuously improve the Quality Management System in compliance with 21 CFR 820 and ISO 13485
Drive a culture of quality, accountability, and inspection readiness across the organization
Partner cross-functionally with Operations, R&D, Regulatory, and Commercial teams
Lead Quality support for:
New product development and line extensions
Commercial manufacturing and product release
Supplier qualification, oversight, and audits
Serve as senior Quality representative during:
FDA inspections
ISO surveillance and recertification audits
Customer complaints, investigations, and field actions
Oversee and ensure effectiveness of:
CAPA, nonconforming material, complaints, and risk management
Design Quality and Design Controls
Training systems and management review
Environmental and microbiological monitoring
Sterilization oversight (outsourced) and cleanroom operations
Qualification
Required
15+ years of Quality Assurance / Quality Engineering experience within medical devices or combination products
10+ years leading teams, including senior-level direct reports
Strong experience with sterile, disposable, single-use medical devices
Proven experience leading FDA and ISO audits
Deep understanding of: ISO 13485, FDA QSR / 21 CFR 820, ISO 14971 (Risk Management), Biocompatibility and sterile product requirements
Bachelor's degree in Engineering, Science, Biomedical Engineering, or related field
ISO 13485 Lead Auditor certification – required (active or commitment to renew)
Valid passport required (occasional travel)
Strong data analysis and decision-making capability (Excel, Minitab or equivalent)
Executive-level communication and presentation skills
Comfortable operating in a fast-moving, hands-on environment
Highly detail-oriented with strong judgment and prioritisation skills
Preferred
Working knowledge of implantable devices strongly preferred
Master's degree preferred
CQE or equivalent certification preferred
Experience in a commercial, revenue-generating medical devices environment
Strong reimbursement dynamics supporting sustained growth
High visibility and impact at the executive level
Opportunity to shape and modernize Quality at a pivotal stage of the company's evolution
Company
Confidential Jobs
Confidential Jobs is operated by ExecThread, Inc. (https://execthread.com).
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Amy Nelson
Managing Partner
Brandon Nolan
Chief Information Security Officer
Company data provided by crunchbase