Quality Systems Specialist – Medical Devices & eQMS

deka; Richmond (NH); On-site; USD 70,000 - 95,000; Full time

Job summary

DEKA Research & Development is seeking a Quality Systems Specialist to advance our medical device QMS in a high-visibility role reporting to the Director of Quality. The position focuses on document control, records, DCNs, and training within a regulated environment.

You will implement and maintain QMS procedures, support audits, and promote QMS awareness across DEKA. A degree in engineering or science or 5+ years in QMS is preferred.

Qualifications

• 2+ years’ experience in a QMS or document-centric environment, degree in Engineering or Science, or 5+ years in QMS without a degree.
• Understanding and working knowledge of ISO 13485 and Quality System regulations is required.
• Proficient in using eQMS systems; experience validating eQMS systems is preferred.
• Experience with documentation in a regulated field such as medical devices.

Responsibilities

• Manage documents, records, DCN, and training processes.
• Review and approve Quality System Records.
• Collaborate with Quality Systems Manager to implement an eQMS.
• Create, implement, and maintain quality system documents; manage changes and distribution.
• Ensure document accuracy, quality, and integrity.
• Process changes for QMS Procedures (SOPs) and track DCNs to approval signatories.
• Support updating procedures and processes to support the QMS.
• File and maintain records manually and electronically.
• Monitor metrics for document management and training efficiency.
• Manage QMS databases for action items and implementation.
• Support external and internal audits.
• Provide training to DEKA personnel as required.
• Promote QMS awareness across DEKA.

Skills

QMS

Documentation

ISO 13485

eQMS

Auditing

Microsoft Office

Communication

Learning ability

Education

Engineering or Science degree

5+ years QMS without degree

Job description

DEKA Research & Development is seeking a Quality Systems Specialist to advance our medical device QMS in a high-visibility role reporting to the Director of Quality. The position focuses on document control, records, DCNs, and training within a regulated environment.

You will implement and maintain QMS procedures, support audits, and promote QMS awareness across DEKA. A degree in engineering or science or 5+ years in QMS is preferred.