Sr. Document Control Specialist

Cirtec Medical; Minneapolis (MN); On-site; USD 60,000 - 80,000; Full time

Job summary

Cirtec Medical in Minneapolis seeks a Sr. Document Control Specialist to implement and maintain the Engineering Change Notice (ECN) system, coordinating between engineering, manufacturing and marketing to document changes per GMP/GLP and regulatory requirements.

You will issue part numbers and ECNs, archive quality records, support training and audits, and ensure compliance with FDA QSR and ISO 13485 while contributing to continuous improvement of the Document Control system.

Qualifications

• 5 years of Document Control experience in the Medical Device Industry.
• Proficiency with PLM software such as Master Control is preferred.
• Knowledge of Cirtec and Customer documentation in ERP/PLM systems.

Responsibilities

• Issue part numbers and ECNs and process documents into the QMS software.
• Communicate with customers for ECN approvals.
• Maintain control records and manufacturing documents.
• Make electronic changes to documents and notify affected departments.
• Maintain related Document Control files and ensure proper filing.

Skills

Document control

Fluent English

Attention to detail

MS Word

MS Excel

PLM knowledge

Education

High School diploma or GED

Tools

Master Control

ERP/PLM systems

Job description

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 Sr. 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 and marketing to en-sure 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. It will also include maintaining/ar-chiving paper and electronic documents such as Paper/electronic documents , training, internal and external auditing documents, filing and maintaining other quality documents as required.

Key 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.
• Responsible for all shipping documentation entry and storage.
• Identify and facilitate continuous improvement efforts to enhance the Document Control System apart of the Quality Management System.
• Responsible for archival of quality system documents/files off-site at storage facility, and retrieval of files when needed.
• Archive /perform data to be used for internal quality metrics.
• Enter all shipping information into database after shipping is complete.
• Complies with company, quality, and safety standards, policies, and procedures.

Must Have:

• High School diploma or GED.
• 5 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.
• Proficient with MS Word, Excel.
• Must be able to read, write and speak fluent English.
• 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:

• Medical Device Manufacturing experience preferred.

Salary Range:

$60,000-80,000 Per year

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.

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