Manufacturing Quality Assurance Inspector

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.