Quality Systems Specialist: Document Control & eQMS

DEKA Research and Development; Manchester (NH); Sur place; USD 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

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Résumé du poste

DEKA Research and Development, on behalf of Millyard Advanced Medical Products, is seeking a Quality Systems Specialist to join a dynamic Medical Device R&D environment. The position reports to the Director of Quality, with high visibility and direct impact on the QMS.

Located in Manchester, NH, the role focuses on documents, records, DCN, training, and change control. You will lead document management, support audits, and promote QMS awareness across DEKA teams.

Qualifications

• 2+ years' experience in QMS or document-centric environment with a degree in Engineering or Science 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 (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

Responsabilités

• 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 quality system documentation and manage changes to process/product documents
• 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

Connaissances

QMS experience

Document control

ISO 13485 knowledge

eQMS proficiency

Regulated medical device docs

Auditing experience

Communication skills

MS Office / Acrobat

Multitasking / reporting

Formation

Engineering or Science degree

5+ years QMS without degree

Outils

eQMS systems

Description du poste

DEKA Research and Development, on behalf of Millyard Advanced Medical Products, is seeking a Quality Systems Specialist to join a dynamic Medical Device R&D environment. The position reports to the Director of Quality, with high visibility and direct impact on the QMS.

Located in Manchester, NH, the role focuses on documents, records, DCN, training, and change control. You will lead document management, support audits, and promote QMS awareness across DEKA teams.