Design Assurance & Quality Engineer

About the role

The Design Assurance & Quality Engineer will lead and implement product development, including the application of design controls, for new products and existing product changes including line extensions. Responsibilities also include creating and maintaining the design history file (DHF), planning, implementing, and reporting on design verification and validation studies, leading the development of manufacturing documentation and manufacturing process validation activities, and managing risk activities from product concept through commercialization.

Design Assurance Duties

• 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.

Quality System Duties

• 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.

Your Profile

• 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.