Change Analysist (experience with Medical Devices)

The Change Analyst will work with our consultants/clients in supporting projects managing labeling, regulatory submissions, quality system documentation and/or clinical study material. The Change Analyst will support the governing change control process for Client and/or RQMIS. In addition, the Change Analyst will provide training to clients and internal staff.

OVERALL RESPONSIBILITIES:

The Change Analyst  will provide overall management of projects, assigned to them by the Sr. Technical Writer, of clients’ needs in the areas of review/approval/control of technical documentation and records. Technical documentation includes product labeling, regulatory submissions, quality system procedures, forms, clinical study documentation, etc. The Change Analyst shall provide day to day activity support for Client and/or RQMIS change control and quality records procedures assuring compliance with applicable Quality Management System (QMS), standards and regulations. Provide training to clients and internal staff on technical writing, good documentation practices and use of Microsoft and Adobe programs in document production/control.

POSITION DUTIES & RESPONSIBILITIES:

Responsible for the timely completion of the following activities:

·      Organize material and finish the given material with required style, terminology, clarity and order.

·      Coordinate with Project Manager and client representatives to establish technical specifications required for publication

·      Support RQMIS/Clients in understanding and following their applicable change control process. Process Change Controls orders (DCOs, ECNs, ECOs, etc.) as defined in the relevant QMS with a goal of completeness and timeliness. Assure all change records are properly stored, maintained and archived according to the relevant QMS. 

·      Maintain/Implement/Utilize any electronic tools (including cloud based) to maintain the QMS of RQMIS/Client. Examples include Matrix and Greenlight Guru.

·      Involvement in the development of product documentation

·      Create and edit Quality System documentation (SOPs, Flowcharts, and so on)

·      Technical file creation/maintenance

·      All documentation conversion

·      Participate in other projects as needed

EDUCATION & PROFESSIONAL EXPERIENCE:

·      Associate or Bachelor’s degree in engineering drafting, engineering tech/technical field or similar work experience

·      1-5 years’ experience in a change analyst role using eQMS systems to manage document control process

·      1 to 3 years’ experience with medical device regulations/standards (including domestic and international markets)

·      Experience creating technical documentation

·      Strong attention to detail

·      Strong computer skills, including Word, Excel, SharePoint, OneDrive, Visio and Adobe Professional and cloud based change control process software.

·      Ability to communicate technical concepts to a non-technical audience

·      Excellent oral and written communication skills

·      Good leadership skills

·      Ability to effectively manage multiple tasks while continuously assessing company and/or departmental priorities

PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by a teammate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·      While performing the duties of this job, the employee is regularly required to, stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment, and interact/observe operations on a manufacturing floor

·      Specific vision abilities required by this job include close vision requirements due to computer work and observing manufacturing processes

·      Light to moderate lifting is required

·      Ability to uphold the stress of traveling

·      Regular, predictable attendance is required; including quarter-driven hours as business demands dictate

The work environment characteristics described here are representative of those a teammate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·      Moderate noise (i.e. manufacturing environment, business office with computers, phone, and printers, light traffic)

·      Ability to work in a confined area

·      Ability to sit at a computer terminal for an extended period of time

TRAVEL:

No more than 10 – 25%