Quality Systems Specialist: eQMS & Documentation

DEKA Research & Development Corp.; Manchester (NH); Hybrid; USD 60,000 - 85,000; Full time

Job summary

DEKA Research & Development is seeking a Quality Systems Specialist to join a dynamic Medical Device R&D environment in Manchester, NH. You will report to the Director of Quality and influence the Quality Management System with cross-functional collaboration.

You will manage documents, records, DCNs, training, and QA records, support audits, and promote QMS awareness across DEKA. A strong background in engineering/science and ISO 13485 knowledge are required.

Qualifications

• 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 and Adobe Acrobat
• Ability to learn custom software programs, multitask, and manage multiple data sources

Responsibilities

• Responsible for documents, records, DCN, and Training processes
• Review and Approve Quality System Records
• Work 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

QMS experience

Documentation

Communication skills

MS Office

Adobe Acrobat

Attention to detail

Education

Engineering degree

Science degree

Tools

eQMS systems

Job description

DEKA Research & Development is seeking a Quality Systems Specialist to join a dynamic Medical Device R&D environment in Manchester, NH. You will report to the Director of Quality and influence the Quality Management System with cross-functional collaboration.

You will manage documents, records, DCNs, training, and QA records, support audits, and promote QMS awareness across DEKA. A strong background in engineering/science and ISO 13485 knowledge are required.