Job Description

Position Summary: Seeking a Document Control Specialist to join our team. This role is responsible for administering and maintaining the company’s-controlled documents, records, and the document control system in accordance with company requirements. This position is a key role in ensuring product and quality system documentation meets defined quality standards requirements. This position also supports all documentation activities including review and release of change requests and provides guidance to users of the document control processes.
Main Responsibilities
Reviews documents for completeness and identifies issues such as typos, grammatical errors, incomplete data, formatting discrepancies, and edits documents on behalf of the originator to correct the issues identified.
Resolves document processing issues.
Ensure documents are processed quickly and correctly.
Creates Engineering Change Orders (ECO)
Collaborate with cross-functional departments to ensure timely completion of change requests and change orders (ECR/ECO’s).
Follow up with document originators if documents are not uploaded in a timely manner after an ECO is created.
Reviews and maintains document logs on a regular basis to ensure data integrity.
Establish and Run weekly CCB meetings
Process document periodic reviews timely and efficiently
Compiles data and generates reports, updates ECO KPI
Ensures training is assigned to appropriate personnel and completed in a timely manner.
Maintains training matrix
Actively send reminders out to trainees if training is pending.
Enter parts, fixtures and assemblies into the inventory control system in a timely manner, soon after the parts are released.
Issuing, auditing and archiving lab notebooks.
Update and maintain SOPs pertaining to document control and training.
Subject Matter Expert for document control and training.
Competencies/Experience
5+ years of experience in the medical device industry or related area.
Must be very detail-oriented, and work well with Engineering, Manufacturing, Quality and R&D personnel.
Advanced computer skills and experience working with Microsoft Office Professional including Word, Excel, PowerPoint, Vizio, and database programs
Advanced document editing and formatting experience
Demonstrated knowledge and basic proficiency with electronic document management systems
Experience with ERP systems
Ability to examine documents such as drawings, procedures, and specifications to verify that Document Control requirements have been met.
Ability to assist personnel with creating documentation in accordance with Standard Operating Procedures and Word templates.
Experience with ISO 13485 document control requirements

Job Tags

Traineeship,

Similar Jobs

Tutoring of Nashville

Reading Tutor- Day shift hours - In-Person only Job at Tutoring of Nashville

Elementary Reading Tutor --Farragut, TN USA 37934 37052 Our company strives to be a world-class organization and we are fully invested in the success of our students, tutors, and employees. We provide in-home, one-on-one tutoring for students of all ages and all subjects...

DETROIT TRAINING CENTER, INC

Career Counselor/Coach Job at DETROIT TRAINING CENTER, INC

...As a Career Counselor/Coach at Detroit Training Center, you will play a crucial role in guiding and supporting individuals through our Workforce Development Training Programs. This program is designed to equip participants with the skills and knowledge needed to pursue...

Department of State Hospitals

STUDENT ASSISTANT - MUSIC THERAPY INTERN Job at Department of State Hospitals

...Job Description and Duties STUDENT ASSISTANT - MUSIC THERAPY INTERN The Department of State Hospitals-Napa, Rehabilitation Therapy Services Department has an intermittent-actual time worked vacancyfor Student Assistant-Music Therapy Intern.Please contact the...

Rescue Mission of Trenton

Licensed Substance Abuse Counselor (LCADC) Job at Rescue Mission of Trenton

...DMHAS. Certifications and License : NJLCADC, NJ LCSW or NJ LPC preferred and a v alid drivers license Must have computer... ...Counseling Services Provide coaching to counselor and counselor interns as requested by the Director of Substance Abuse Counseling...

Focus on Life Biz

Customer Success Manager Job at Focus on Life Biz

...About The Job Seeking Motivated Self-Starter with Customer Success Manager Experience. Are you a motivated, enthusiastic individual... ...to start your journey with us! Ideal for candidates seeking remote work, this online business offers independence, empowerment and...

Document Control Specialist Job at huMannity Medtec, Santa Clarita, CA

bzl1WFFlZ2IzQmhGWTFoaURNNnpHVFRTMHc9PQ==