Quality Specialist at DEKA Research and Development

DEKA R&D has an immediate 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.

How you will make an impact:

• 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 relative 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.