DEKA Research & Development
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DEKA R&D has an opening for a Quality Specialist to work in the Quality Department in a dynamic Medical Device Research and Development environment. The position reports to the Director of Quality. The Quality Specialist is actively involved with everyday quality assurance operational tasks for ongoing product development projects and commercially released products.
Overview
Quality Specialist role supporting QA activities in a regulated environment to ensure product quality and compliance throughout development and release. Responsibilities
Review and approve Quality System Records Support updating procedures and processes to support the QMS Support the site Corrective and Preventive Action program Provide QA support related to DHR Review/inspections and final acceptance of materials/products Review labels for accuracy and precision Initiate non-conforming materials reports and segregate / control non-conforming materials as required Review and close complaint files per complaint requirements File and maintain records manually and electronically Support QMS collection and trending of quality data Manage QMS databases for action items and implementation Support vendor qualification and management Support external and internal audits Support as backup to Training Coordinator, CAPA Coordinator, and Calibration Coordinator Provide training as required to DEKA personnel Promote QMS awareness to non-QA departments throughout DEKA Skills needed to be successful
Preferred 2+ years’ experience in Quality Assurance in an FDA regulated environment – with QSR (21 CFR Part 820) and ISO 13485 experience if possible. Experience with documentation in a regulated field such as medical device Prior auditing experience is a plus Strong written/verbal communication skills Ability to learn custom software programs Multitask and carry tasks through to completion Manage multiple sources of data and develop reports 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 and 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. Seniority level
Entry level Employment type
Full-time Job function
Quality Assurance
#J-18808-Ljbffr
Quality Specialist role supporting QA activities in a regulated environment to ensure product quality and compliance throughout development and release. Responsibilities
Review and approve Quality System Records Support updating procedures and processes to support the QMS Support the site Corrective and Preventive Action program Provide QA support related to DHR Review/inspections and final acceptance of materials/products Review labels for accuracy and precision Initiate non-conforming materials reports and segregate / control non-conforming materials as required Review and close complaint files per complaint requirements File and maintain records manually and electronically Support QMS collection and trending of quality data Manage QMS databases for action items and implementation Support vendor qualification and management Support external and internal audits Support as backup to Training Coordinator, CAPA Coordinator, and Calibration Coordinator Provide training as required to DEKA personnel Promote QMS awareness to non-QA departments throughout DEKA Skills needed to be successful
Preferred 2+ years’ experience in Quality Assurance in an FDA regulated environment – with QSR (21 CFR Part 820) and ISO 13485 experience if possible. Experience with documentation in a regulated field such as medical device Prior auditing experience is a plus Strong written/verbal communication skills Ability to learn custom software programs Multitask and carry tasks through to completion Manage multiple sources of data and develop reports 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 and 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. Seniority level
Entry level Employment type
Full-time Job function
Quality Assurance
#J-18808-Ljbffr