Document Control Specialist I

Description

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. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

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.

Key Responsibilities:

• Issue part numbers and ECN's 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.

Must Have:

• 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.

Good to have:

• Master Control is preferred.

Hourly Pay Range: $26-$34 hourly, depending on experience and qualifications.

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.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.