Design Assurance, Quality Engineer

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 non‑conforming 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.
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