Quality Systems Specialist

DEKA R&D has an immediate opening for a Quality Systems Specialist to work in the Quality Department in a dynamic Medical Device Research and Development environment.  The position reports to the Quality System Management Team Leader.  This is a high visibility role with a significant direct impact in the Quality Management System.

How you will make an impact:

• Review and Approve Quality System Records
• Process changes for QMS  Procedures (SOPs)
• Make red-line changes
• Process ECOs to approval signatories
• Make new master documents, archive and distribute via electronic system
• Track training for QMS documents within the Change Order process
• Track open impacts to completion
• Support updating procedures and processes to support the QMS
• Support the site Corrective and Preventive Action program
• File 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
• Lead and support external and internal audits
• Support as backup to Training Coordinator and CAPA Coordinator
• Provide training as required to DEKA personnel 
• Promote QMS awareness to non-QA departments throughout DEKA

Skills needed to be successful:                                

• 2+ years’ experience in QMS or document centric environment with degree in Engineering or Science/background preferred or 3+ years’ QMS or document centric environment without degree
• Experience with documentation in a regulated field such as medical
• Prior auditing experience and qualification (ex: ISO13485 Lead Auditor)
• Excellent 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.

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