Quality Systems Specialist

About the role

DEKA R&D, on behalf of Millyard Advanced Medical Products, is looking for a Quality Systems Specialist to work in a dynamic Medical Device Research and Development environment. The position reports to the Director of Quality. This is a high visibility role with a significant direct impact in the Quality Management System.

Responsibilities

• Responsible for documents, records, DCN, and Training processes
• Review and Approve Quality System Records
• Works closely with the Quality Systems Manager to implement an eQMS system
• Create, implement, and maintain existing quality system documentation and manage changes to process/product documents, including format and numbering, record retention, change control and document distribution
• Ensure document accuracy, quality, and integrity
• Process changes for QMS Procedures (SOPs)
• Make red-line changes
• Process DCNs 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
• File and maintain records manually and electronically
• Establish, monitor, and respond to metrics on the efficiency of the document management and training processes and its ability to support the business
• Manage QMS databases for action items and implementation
• Support external and internal audits
• Provide training as required to DEKA personnel
• Promote QMS awareness to non-QA departments throughout DEKA

Skills

• 2+ years’ experience in QMS or document centric environment with degree in Engineering or Science degree/background or 5+ years’ QMS or document centric environment without degree
• Understanding and working knowledge of ISO 13485 and Quality System regulation is required
• Proficient in the use of eQMS systems; experience validating eQMS system is preferred
• Experience with documentation in a regulated field such as medical device
• Prior auditing experience is a plus
• Strong written/verbal communication skills
• Strong computer skills, including Microsoft Office applications (i.e., Word, Excel, PowerPoint) and Adobe Acrobat
• Ability to:
  • Learn custom software programs
  • Multitask and carry tasks through to completion
  • Manage multiple sources of data and develop reports