Design Assurance, Quality Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and execute product development initiatives, encompassing the application of design controls for both new products and modifications to existing ones, including line extensions.

• Develop and uphold the design history file (DHF), which includes creating relevant specifications such as user requirements and design specifications.

• Strategize, execute, and document design verification and validation studies, including bench testing and pre-clinical trial protocols and reports.

• Guide the creation of manufacturing documentation and the activities related to manufacturing process validation.

• Manage risk assessment activities from the initial product concept through to commercialization.

• Collaborate with Regulatory Affairs to facilitate submissions for pre-market authorizations within the United States.

• Work in close partnership with contract manufacturers and other suppliers to launch new projects and ensure that supply chain performance and quality standards are met.

• Conduct lot release activities, which involve reviewing batch records, device history records (DHRs), and process documentation to ensure accuracy and completeness.

• Assist with the assessment, evaluation, and documentation of nonconforming materials.

• Support the post-market phase, including handling product complaints, managing risk, and conducting post-market surveillance activities.

• Aid in conducting supplier qualification and performance evaluation activities.

• Communicate quality-related issues to suppliers and assist in resolving these issues.

• Contribute to internal audits and provide support during external audits and inspections (e.g., FDA, ISO).

⛳️ Requirements

• A Bachelor’s degree in life sciences, material sciences, engineering, or a related discipline is required.

• Experience in the medical device industry is essential; a minimum of 3 years is preferred.

• Familiarity with design controls and a general understanding of the ISO 13485 standard; formal ISO 13485 training is advantageous.

• Experience in a small business or startup environment is preferred.

• Familiarity 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