Document Control Specialist I

About us

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients.

About the role

The Document Control Specialist I 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.

Responsibilities

• Issue part numbers and ECNs and processing documents into the QMS software (i.e., Master Control, Syteline, etc.)
• Communicate with customer for obtaining ECN approval
• Compile and maintain control records such as release drawings, project documents, quality system documents and manufacturing documents
• Handle electronic changes to documents, release documents, and notifies affected departments
• Maintain related Document Control files
• Ensure 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

Requirements

• HS Diploma or GED required
• 2 years of Document Control experience in the Medical Device Industry required
• Prior experience with PLM software system
• Strong knowledge in implementing, processing, and maintaining company and customer documentation in ERP and PLM Software System
• Must be able to read, write and speak fluent English
• Proficient with MS Word and Excel
• Knowledge of document control procedures with data storage, maintenance, revision, and archival background
• Familiarity with FDA Quality System Regulation (QSR) and ISO 13485

Nice to have

• Master Control experience is preferred

Pay

Hourly pay range: $26-$34, depending on experience and qualifications.

Benefits

• Training and career development
• Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid Time Off
• 401(k) retirement savings with a company match