Quality Document Control Specialist

Roles & Responsibilities

Essential / Key Job Responsibilities
- Participates in regulatory compliance audits and inspections.
- Participates in investigations.
- Completes applicable job-specific training.
- Effectively manage the end-to-end change lifecycle and identify process improvements where possible.
- Day to day management of change requests
- Reporting of change to both internal and customer management teams
- The position will identify and drive continuous improvements to the quality and efficiency of the change management process
- Applies skills and develops documentation including operating procedures, process flow charts and manufacturing procedures
- Documentation origination, editing and revision
- Creation of change request and associated paperwork utilizing the Electronic Document Management System (EDMS)
- Uses various computer software applications to complete assigned work activities
- Understanding of compliance requirements and regulations Ability to generate report(s) utilizing the systems
- Work with teams to determine status of projects/document changes and assist with driving project/document changes to completions
- Be able to develop and speak to metrics and workload tracking
- Be actively engaged in meetings
- Participates in the development of solutions to Quality System problems and/or non-compliance.
- Assists in maintenance of department, site / business unit, and corporate procedures and policies.
- Demonstrates knowledge of operating procedures and expertise in a specific functional area
- Accountable for the execution of specific tasks with moderate discretion and with oversight from a supervisor
- Carries out tasks and activities
- Applies specialized knowledge/skills to perform routine and non-routine work of a group or department
- Other duties, as assigned

Experience Required

Required Qualifications
I:
- Basic understanding of regulations.
- Advanced language proficiency in reading, writing, understanding, and communicating in English.
- Attention to detail.
- Intermediate computer skills and software applications, including experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint)
- Intermediate organizational and administrative skills
- experience in working in a cross-functional team environment as well as the ability to function independently
- Ability to gather and organize information
- Ability to grasp technical terms, processes, and methods

Skills & Certifications

- Ability to handle a variety of projects at the same time
- Ability to prioritize and organize a busy and changing workload
- Ability to work in a team enviroment and/or independently with little supervision
- Works collaboratively with a variety of people at all levels within the organization to ensure effective communication and success of key initiatives
- Resolve problems by clarifying issues; researching and exploring answers and alternative solutions; implements solutions; escalates unresolved problems
- Ability to be flexible in work schedule, including a willingness to work overtime as needed
- Positive and Professional attitude

Eligibilities & qualifications

• 3 Must haves on the resume:

Quality Management Systems experience, Document Controls experience, Medical device industry experience
• Education requirements: Highschool diploma and at least 1+ year experience in documentation related position.

This position is responsible for the creation and processing of all change request packets, creation of controlled documents, tracking of packets and all associated paperwork involved. This requires participation as an active team member in cross functional teams and ownership of project team documentation. Responsibilities also include the origination, editing and revision of technical documentation. This position will also assist with the migration between two different MasterControl systems.