Job Description

We are seeking a Quality Engineer who will provide quality oversight for device and combination product development and commercial manufacturing, including activities performed by contract manufacturing partners. This role ensures compliance with applicable regulatory requirements and internal quality systems, with a strong focus on supplier quality, change management, and lifecycle product quality.

Responsibilities

• Support design control activities, including design reviews, DHF documentation, and risk management
• Provide quality oversight of contract manufacturers, ensuring compliance with GMP, quality agreements, and regulatory requirements
• Review and approve validation protocols and reports (process, test method, packaging) generated internally and by external partners
• Lead or support change control activities related to device and manufacturing changes, including impact assessments and implementation
• Support supplier qualification, monitoring, and performance management activities
• Lead or support investigations (nonconformances, deviations, complaints) and drive CAPA to closure
• Participate in internal and external audits, including supplier audits and regulatory inspections
• Collaborate cross-functionally with internal teams and external partners to ensure product quality across the lifecycle
• Analyze quality data and supplier performance trends to drive continuous improvement
• Ensure compliance with 21 CFR Part 820, ISO 13485, and combination product regulations (21 CFR Part 4)

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 5+ years of experience in medical device or combination products
• Hands-on, in-depth experience supporting quality engineering activities for nasal inhalation or drug delivery devices, with demonstrated ownership of design controls, risk management, validation oversight, and lifecycle quality compliance
• Demonstrated expertise with nasal inhalation systems, including device functionality, performance testing (e.g., spray characterization, dose uniformity), and application of quality and regulatory requirements for combination products
• Experience working with contract manufacturers and supplier quality management
• Strong knowledge of design controls, risk management (ISO 14971), and GMP
• Experience supporting audits and regulatory inspections
• Strong problem-solving skills and attention to detail

Location

• Remote
• Eastern Time Zone is preferred

Employee Type

• W2 or 1099

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com

Equal Opportunity Employer Minorities/Women/Veterans/Disabled