Our client is looking for a remote Quality Engineer II supporting enterprise-level projects, with a strong emphasis on design control activities and quality oversight. Although the general job description includes manufacturing, supplier quality, process validation, CAPA, SPC, and design transfer responsibilities, the current need is not limited to traditional plant-floor quality support. We are looking for someone who can support project teams remotely and provide quality engineering input throughout the product lifecycle. Ideal candidate background will have:

• Medical device quality engineering
• Design controls, Design History File (DHF) review, and Risk Management File (RMF) ownership/review
• Design transfer and process validation
• FDA-regulated or ISO 13485 environments
• CAPA, root cause analysis, and effectiveness verification
• Risk management tools such as FMEA
• Statistical methods such as SPC, DOE, capability analysis, sampling plans, and gage R&R
• Remote project support across cross-functional teams

Strong indicators of fit A strong candidate should be able to explain examples of:

• Reviewing or approving DHF and RMF deliverables
• Supporting design milestones or design transfer
• Participating in process validation activities such as IQ/OQ/PQ
• Applying risk-based quality tools
• Supporting CAPA or nonconformance investigations
• Working with design engineering, manufacturing engineering, suppliers, or project teams

Preferred qualifications

• Bachelor's degree in an Engineering discipline or a related subject
• CQE certification
• 5+ years relevent in a regulated environment with a strong preference for Medical device manufacturing experience
• Strong process and product design validation background
• Experience supporting multi-site or enterprise-level projects
• Demonstrated ability to work independently in a remote environment