Senior Medical Device Document Control Specialist

Cirtec Medical; Minneapolis (MN); On-site; USD 60,000 - 80,000; Full time

Job summary

Cirtec Medical in Minneapolis seeks a Sr. Document Control Specialist to implement and maintain the Engineering Change Notice (ECN) system, coordinating between engineering, manufacturing and marketing to document changes per GMP/GLP and regulatory requirements.

You will issue part numbers and ECNs, archive quality records, support training and audits, and ensure compliance with FDA QSR and ISO 13485 while contributing to continuous improvement of the Document Control system.

Qualifications

• 5 years of Document Control experience in the Medical Device Industry.
• Proficiency with PLM software such as Master Control is preferred.
• Knowledge of Cirtec and Customer documentation in ERP/PLM systems.

Responsibilities

• Issue part numbers and ECNs and process documents into the QMS software.
• Communicate with customers for ECN approvals.
• Maintain control records and manufacturing documents.
• Make electronic changes to documents and notify affected departments.
• Maintain related Document Control files and ensure proper filing.

Skills

Document control

Fluent English

Attention to detail

MS Word

MS Excel

PLM knowledge

Education

High School diploma or GED

Tools

Master Control

ERP/PLM systems

Job description

Cirtec Medical in Minneapolis seeks a Sr. Document Control Specialist to implement and maintain the Engineering Change Notice (ECN) system, coordinating between engineering, manufacturing and marketing to document changes per GMP/GLP and regulatory requirements.

You will issue part numbers and ECNs, archive quality records, support training and audits, and ensure compliance with FDA QSR and ISO 13485 while contributing to continuous improvement of the Document Control system.