Job Title: Technical Writer
Location: Pittsburgh, PA 15235
Hiring Mode - Direct Hire
Salary - $60000-69750/Yearly/W-2
Job Description
Technical Writer - Medical Devices Job Details Client is seeking individuals who combine excellent Technical Writer Medical Devices with the ability to function effectively both as part of a team or on an individual basis to bring their talent to our team.
PRINCIPAL RESPONSIBILITIES: 2+ years of experience as a Technical Writer (for SOP, QMS etc.) in the medical device industry Practical knowledge of standards and regulations pertaining to the medical device industry.
Experience with CAD and Visio You will be trained on client products and SOPs / templates Maintain a backlog of all change requests to client's QMS design controls procedures/WIs/forms, in response to CAPAs or for efficiency improvements.
Plan and execute the defining the specific procedural updates needed and gaining cross-functional alignment Updating the relevant procedures Release in QMS per document change process Plan and roll-out training. Training and coaching implementation.
Coordinating with cross-functional teams. Gathering feedback on execution from the project teams. Good Communication skills and attention to detail. BACKGROUND AND SKILLS REQUIRED: Bachelor’s degree preferably in Engineering (Mechanical engineering degree a plus) Understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, and ISO13485. 3+ years writing effective Medical and Technical narratives. Experience with CAD and Visio.
Experience in design quality assurance in medical device is a plus. Must have good computer skills. Able to think critically and ask pertinent questions to gather necessary information.
Must have good computer skills.
Good problem solving and analytical skills. Attention to detail. Works autonomously within established procedures and practices to meet complaint timeline requirements
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