Senior Medical Device Document Control Lead

Cirtec Medical; Brooklyn Park (MN); On-site; USD 40,000 - 50,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) retirement with company match

Paid Time Off

Training and career development

Job summary

Cirtec Medical in Brooklyn Park, Minnesota is seeking a Sr. Document Control Specialist to implement and maintain the Engineering Change Notice system for product improvements, repairs and new development.

You will coordinate between engineering, manufacturing, and marketing to ensure proper documentation in GMP/GLP compliant procedures. Responsibilities include issuing ECNs, maintaining records, and supporting quality systems audits.

Qualifications

• High School diploma or GED.
• 5 years of Document Control experience in the Medical Device Industry.
• Familiarity with Master Control or similar PLM software.
• Strong knowledge of Cirtec and customer documentation in ERP/PLM systems.
• Detail-oriented and flexible.

Responsibilities

• Issue part numbers and ECNs and process documents in QMS software.
• Coordinate with engineering, manufacturing and marketing for changes.
• Maintain and archive quality documents and records.
• Update CAPA, NCMR, and complaint files.
• Assist with training documentation and quality system reporting.

Skills

Document Control

Attention to detail

MS Word

MS Excel

English fluency

FDA QSR ISO13485 knowledge

Education

High School diploma or GED

Tools

MasterControl

Job description

Cirtec Medical in Brooklyn Park, Minnesota is seeking a Sr. Document Control Specialist to implement and maintain the Engineering Change Notice system for product improvements, repairs and new development.

You will coordinate between engineering, manufacturing, and marketing to ensure proper documentation in GMP/GLP compliant procedures. Responsibilities include issuing ECNs, maintaining records, and supporting quality systems audits.