Job Description

At huMannity Medtec 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!

Position Summary : Seeking an additional Document Control Specialist to join our team as we are growing!. 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.

Summary of Main 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.

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

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