About us:

For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

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 challenge, 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:

• Responsible for updating job tracker daily after reviewing each job.
• Responsible for getting corrections from operators as needed and track operator’s GDP errors
• 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 ensuring documents are filed correctly and maintained per established procedures.
• Perform reviews for all jobs from the manufacturing area for counts, accuracy for data and reviewing all paperwork that follows with the parts.
• Work with planners to update monthly schedules and report the updates to the staff of each department.

Must Have:

• 2 years of Document Control experience in the Medical Device Industry required.
• Knowledge of document control procedures with data storage, maintenance, revision, and archival background.
• Strong knowledge in implementing, processing, and maintaining company and customer documentation in ERP and PLM Software System.

Good to have:

• Prior experience with PLM software system, such as Master Control is preferred.
• Familiarity with FDA Quality System Regulation (QSR) and ISO 13485.

Hours:

Monday to Friday, 7:30 am - 4:00 pm

Cirtec Medical Corporation considers everyone 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 its related companies fully endorse equal opportunity. 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 an enjoyable 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 stage of your career and life. 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.