Quality Systems Specialist

• 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 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 and CAPA Coordinator
• Provide training as required to DEKA personnel
• Promote QMS awareness to non-QA departments throughout DEKA

• Preferred experience 2+ years' experience in QMS or document centric environment with degree in Engineering or Science degree/background or 3+ years' QMS or document centric environment without degree
• 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 & 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.