Technical Writer/Change Analyst

1 day ago

Boston MA United States ZipRecruiter Full time

Job Description

RQMIS, Inc. is a fast growing, medical device/biotechnology consultancy with a focus on regulatory strategy/submissions, clinical study design/management and quality systems design/compliance/auditing. We are looking for an experienced Technical Writer/Change Analyst for our Amesbury, MA office. This is a wonderful opportunity for someone who enjoys a variety of projects and working with a dynamic team of people in a thriving company.

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

Title : Technical Writer/Change Analyst

Hours : 40 hours per week

Status : This position is a full-time employment.

OVERALL RESPONSIBILITIES

The Technical Writer will provide overall management of technical writing projects assigned to them by the Sr. Technical Writer, focusing on clients’ needs in the areas of design, creation, and maintenance of technical documentation. 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 the use of Microsoft and Adobe programs in document production.

POSITION DUTIES & RESPONSIBILITIES

Responsible for the timely completion of the following activities:

  1. Organize material and finalize the given material with required style, terminology, clarity, and order.
  2. Coordinate with Project Manager and client representatives to establish technical specifications required for publication.
  3. Support RQMIS/Clients in understanding and following their applicable change control process. Process Change Control 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.
  4. Maintain/Implement/Utilize any electronic tools (including cloud-based) to maintain the QMS of RQMIS/Client. Examples include Matrix and Greenlight Guru.
  5. Involvement in the development of product documentation.
  6. Develop/Publish regulatory submissions: 510(k), IDE, PMA, etc.
  7. Create and edit Quality System documentation (SOPs, Flowcharts, and so on).
  8. Technical file creation/maintenance.
  9. All documentation conversion.
  10. Participate in other projects as needed.

EDUCATION & PROFESSIONAL EXPERIENCE

  • Bachelor’s degree in engineering/technical field (biomedical, mechanical, chemical, electrical, biochemical engineer, chemist, microbiologist, etc.), or similar work experience.
  • 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, as well as 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%

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