Quality Engineer - Single-Use medical disposables (Buffalo)

My client is a cutting-edge medical device manufacturer and need to add to staff in this critical role. Ideally, we would like to see an experienced Quality Engineer with medical disposable products expertise, such as IV sets, etc.

Position Summary : Quality Engineer is responsible for supporting the design, development, and production of single-use medical devices by ensuring compliance with regulatory and quality system requirements. This role plays a key part in risk management, verification activities, supplier quality, and process validation related to disposable components such as tubing sets, connectors, filters, and fluid path devices.

Key Responsibilities :

• Product Development & Design Control
• Participate in design control activities including design inputs / outputs, verification, and risk management
• Review and support development of component specifications and test methods for single-use assemblies
• Ensure traceability of requirements and test results within the Design History File (DHF)
• Risk Management
• Contribute to hazard analysis, FMEAs, and use-related risk assessments (URRAs)
• Support risk control implementation and residual risk justification for fluid path components
• Supplier & Incoming Quality
• Collaborate with suppliers on component qualification and incoming inspection criteria
• Lead or support supplier audits and monitor performance for single-use device vendors
• Investigate and determine disposition of nonconforming materials (NCRs)
• Process Validation & Manufacturing Support
• Assist in process validation activities related to molding, bonding, welding, or packaging of disposables
• Review of manufacturing documentation including batch records and Device History Records (DHRs)
• Participate in CAPA investigations and root cause analysis related to production quality issues
• Quality Systems & Documentation
• Author and revise quality system documents (SOPs, WIs, forms) related to disposables
• Support internal audits and regulatory inspections
• Ensure records are maintained in compliance with 21 CFR Part 820, ISO 13485, and applicable guidance (e.g., ISO 14971, ISO 10993)

Qualifications :

Preferred Skills :