DEKA R&D has an immediate opening for a Manufacturing QA Inspector to work in a dynamic Medical Device Research, Development, and Manufacturing company. This position reports to the Manufacturing QA Manager and is a highly visible role with significant and direct impact on the manufacturing process and success of projects.

Responsibilities:

• Perform in-process inspections of manufactured product according to device specifications and related documentation

• Support Engineering to ensure QMS compliance is met during all phases of research and development.

• Participate in the development and/or revision of Operation and Inspection Procedures

• Review Work Orders, Device History Records, and other documentation for compliance to established procedures, Good Documentation Practices (GDP), and the broader Quality Management System (QMS)

• General administration of the Nonconforming material process, including participation in Material Review Board meetings to facilitate disposition of rejected material, and use critical thinking to determine the best approach

• Review and provide feedback on proposed process changes when applicable to inspection activities, whether individually or in a cross-functional setting

• Perform audits against written procedures to help identify and recommend any necessary changes to the process

• Perform in-process inspection(s) in an ISO 14644 standard clean room

Qualifications:

• High School graduate or equivalent

• At least 3 years experience in a quality control role, medical device preferred

• Able to read and interpret technical documentation such as:

• Drawings, blueprints, operating procedures, ECOs, rework orders, etc...

• A basic understanding of proper handling of components sensitive to Electro-Static Discharge (ESD)

• Basic computer skills and technical knowledge; comfortable learning new software

• Familiar with AQL sample inspections

• Strong attention to detail

• Excellent communication skills, both verbal and written

• Self-motivated, Organized, and Excellent Prioritization skills

About DEKA:

One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development, where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.

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