Design Assurance & Quality Engineer

Heraeus Electro-Nite is a family-owned global technology leader dedicated to driving innovation across key industries. They are seeking a Design Assurance & Quality Engineer to lead product development, manage design controls, and ensure quality compliance in the medical device sector.

Responsibilities:

• 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)
• Participate in CAPA investigations and track CAPA progress through verification of effectiveness
• Help provide QMS training and subject matter support for fellow employees
• Administer user set up and employee training in QMS support software and monitor training
• Serve as document control coordinator in QMS support software
• Identify opportunities to improve processes, reduce defects, and enhance overall product quality
• Monitor and trend quality metrics and escalate signals

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