Design Assurance, Quality Engineer

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Minor Hotels Europe and Americas

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1978

Minor Hotels is a global hospitality leader with a network of more than 560 hotels across six continents.

📋 Description

• Lead and implement product development, including the application of design controls, for new products and existing product changes including line extensions. • Create and maintain the design history file (DHF), including development of related specifications such as user requirements and design specifications. • Plan, implement, and report on design verification and validation studies, including bench and pre-clinical test protocols and reports. • Lead the development of manufacturing documentation and manufacturing process validation activities. • Responsible for risk management activities from product concept through commercialization. • Partner with Regulatory to support submissions for pre-market authorizations in the US. • Work closely with contract manufacturers and other suppliers to implement new projects and ensure supply chain meets performance and quality requirements. • Perform lot release, including reviewing batch records, device history records (DHRs), and process documentation for accuracy and completeness. • Support the intake, evaluation, and documentation of nonconforming materials. • Support post-market phase including product complaint handling, risk management, and post-market surveillance activities. • Help conduct supplier qualification and performance evaluation activities. • Communicate quality issues to suppliers and support resolution tasks. • Assist with internal audits and support external audits and inspections (e.g., FDA, ISO).

🎯 Requirements

• Bachelor’s degree in life sciences, material sciences, engineering or a related field required. • Experience in medical device industry required; minimum 3 years preferred. • Working knowledge of design controls and general knowledge of the ISO 13485 standard; formal ISO 13485 training is a plus. • Experience in a small company or start-up environment preferred. • Experience with QMS support software / document control systems is a plus.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options