Job Description

We are looking for an experienced and highly motivated Document Control Specialist to join our Quality Assurance team and help us improve processes, increase efficiency, and maintain our ISO 13485 certification.

Position Summary: The Document Control Specialist 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.

Responsibilities

• Reviews documents for completeness and identifies issues such as typos, grammatical errors, incomplete data, formatting discrepancies etc. and edits documents on behalf of the originator to correct the issues identified.
• Resolves document processing issues.
• Ensure documents are processed quickly and correctly.
• Processes Document Change requests in a timely manner.
• 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.
• Update and maintain SOPs pertaining to document control and training.
• Subject Matter Expert for document control and training.

Experience:

• 3+ 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.
• Ability to work independently on multiple assignments with competing priorities.
• Willingness to assist in performing Quality Assurance tasks.
• Experience with ISO 13485 or ISO 9001 document control requirements

At huMannity Medtec we will give you the opportunity to change the lives of millions who are suffering – it’s what we do! We have been at the bleeding edge of medical technology innovation for over 40 years, and we are looking for smart, motivated, and diverse people to help us advance our mission in a truly meaningful way. We will give you what you need to succeed, thrive, and progress, including a tremendous workplace culture featuring a collaborative spirit, fun-loving team, and experienced leadership.

We truly understand the need for balance and, among other things and offer a 9/80 schedule with every other Friday off. That’s 26 long weekends a year!

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