Medical Device Quality Lead: Inspection & Release

TTI Consumer Power Tools, Inc.; United States; Presencial; USD 80 000 - 105 000; Tempo integral

Resumo da oferta

TTI Consumer Power Tools, Inc. seeks a seasoned Quality Inspector to support FDA and ISO 13485 compliance in incoming part inspection, documentation, and final release of finished goods.

You will interface with Supply Chain, Suppliers, and Manufacturing Assemblers while working with middle management daily. The role requires 5+ years in medical device quality inspection, a Bachelor’s or Associate’s degree, and strong communication.

Qualificações

• 5+ years of quality inspection experience in Medical Device or related field.
• Bachelor’s Degree or Associate's Degree with appropriate quality experience.
• Excellent communication skills: able to read and understand technical reports, specifications, and communicate clearly with the customer.
• Experience with FDA 21 CFR 820 and ISO 13485 knowledge preferred.
• Experience with SAP a plus.

Responsabilidades

• Proactively ensure smooth team operations and effective collaboration as it relates to the performance of incoming receipt, inspection, and release of purchased parts and materials to Production.
• Manage the Finished Product Release process – document review, product release, and Certificate of Conformance creation.
• Leadership abilities to train, develop, and motivate the Quality Control team.
• Be a contact point for the Quality Control team members.
• Assist the Quality Engineers in nonconforming process of defective parts and in-process units.
• Efficiently execute tasks and maintain quality by monitoring processes and parts; provide immediate feedback with alternative options as necessary.

Conhecimentos

Quality inspection

Leadership

Communication

Self-directed

Formação académica

Bachelor’s Degree

Associate's Degree

Ferramentas

MS Office

Excel

Word

PowerPoint

SAP

Descrição da oferta de emprego

TTI Consumer Power Tools, Inc. seeks a seasoned Quality Inspector to support FDA and ISO 13485 compliance in incoming part inspection, documentation, and final release of finished goods.

You will interface with Supply Chain, Suppliers, and Manufacturing Assemblers while working with middle management daily. The role requires 5+ years in medical device quality inspection, a Bachelor’s or Associate’s degree, and strong communication.