Quality Systems Specialist

DEKA Research & Development
Manchester
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Experience: 2+ yearsSkills: ["Communication","Multitasking"]

Own key quality system documentation and record processes in a medical device R&D environment. Review and approve QMS records, manage document changes (DCNs, records retention, distribution), and maintain QMS databases and metrics. Partner with the Quality Systems Manager to implement and support an eQMS system, process SOP/QMS procedure updates, and support internal and external audits. Provide training and promote QMS awareness across DEKA teams.

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DEKA Research & Development
DEKA Research & Development
6 days ago

Quality Systems Specialist

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Source: Company careers pageValidated by: Fursa AI
Last checked: 5 hours agoStatus: Live
Reposted: similar role first listed 6 months ago

Job Summary

Own key quality system documentation and record processes in a medical device R&D environment. Review and approve QMS records, manage document changes (DCNs, records retention, distribution), and maintain QMS databases and metrics. Partner with the Quality Systems Manager to implement and support an eQMS system, process SOP/QMS procedure updates, and support internal and external audits. Provide training and promote QMS awareness across DEKA teams.
Location: Manchester
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Mid level

Key Responsibilities

  • •Manage documents, records, DCNs, and training processes within the Quality Management System, including review/approval of QMS records.
  • •Create, implement, and maintain quality system documentation; manage changes to process/product documents, including retention, change control, and distribution.
  • •Process DCNs through approval signatories and make red-line changes; create new master documents and archive/distribute via electronic systems.
  • •Track QMS document training and open impacts to completion; maintain QMS databases and monitor metrics for document management and training efficiency.
  • •Support updating QMS procedures/processes, file and maintain records (manual and electronic), provide training, and support internal/external audits.

Key Requirements

  • •2+ years of experience in a QMS or document-centric environment with an Engineering or Science degree, or 5+ years without a degree.
  • •Understanding and working knowledge of ISO 13485 and Quality System regulations.
  • •Proficiency using eQMS systems (experience validating eQMS systems is preferred).
  • •Experience documenting within a regulated field such as medical device.
  • •Strong written and verbal communication skills.
Experience:2+ yearsMedical device
Skills:CommunicationMultitasking
Tech Stack:EQMSMicrosoft OfficeWordExcelPowerPointAdobe Acrobat

Company Brief

DEKA Research & Development
DEKA Research & Development is a private R&D and product development firm founded by Dean Kamen that designs and manufactures medical devices, mobility systems, energy and water solutions, and low-volume production prototypes for healthcare and industrial customers.
Industry: Medical Devices
Company Size: Large (251 to 1,000 employees)
Growth: Established Company
Headquarters: Manchester, United States
Founded: 1982
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