Brooklyn Park - MN Other 2 months ago

JOB SUMMARY

The Document Control Specialist implements and maintains the Engineering Change Notice System. These changes will include product improvements, repairs, and new product development. Coordinates the interaction between engineering, manufacturing, field operations, and marketing to ensure appropriate changes are documented. Provides documentation such as good manufacturing practices (GMP) and good laboratory practices (GLP) procedure manuals and change authorization in accordance with company policies and government regulations.

ESSENTIAL RESPONSIBILITIES

  • Responsible for issuing part numbers and ECN’s and processing documents into the QMS software (i.e. Master Control, Syteline, etc.)
  • Responsible for communicating with customer for obtaining ECN approval.
  • Responsible for compiling and maintaining control records such as release drawings, project documents, quality system documents and manufacturing documents.
  • Responsible for making electronic changes to documents, release documents, and notifies affected departments.
  • Responsible for maintaining related Document Control files.
  • Responsible for ensuring documents are filed correctly and maintained per established procedures.
  • Perform database searches, minor data analysis, and reporting to assist Quality Assurance team.
  • Maintain logs and update CAPA, NCMR, Complaint and other Quality Systems files.
  • Prepare reports and memorandums.
  • Ensure Proper upkeep of quality records and documents.
  • Coordinates Training program, which includes facilitating the training and input results into the training QMS system.
  • Complies with company, quality and safety standards, policies, and procedures
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

QUALIFICATIONS

  • 2-3 years of Document Control experience in the Medical Device Industry required
  • Prior experience with PLM software system, such as Master Control is preferred
  • Strong knowledge in implementing, processing, and maintaining Cirtec and Customers documentation in ERP and PLM Software System
  • Extremely detail-oriented work habits
  • Flexible and motivated attitude
  • Must be able to read, write and speak fluent English
  • Proficient with MS Word, Excel
  • Knowledge of document control procedures with data storage, maintenance, revision and archival background
  • Familiarity with FDA Quality System Regulation (QSR) and ISO 13485

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process

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