Job Description

We are seeking individuals who combine excellent Technical Writing with the ability to function effectively both as part of a team or on an individual basis to bring their talent to our team.

This role will be onsite in Pittsburgh, PA .

Mandatory Skills: Technical Writing, CAD and Visio.

Experience: Minimum of 2 years.

Expected Annual Pay for this role: Upto $69,750

Based on the position, the role is also eligible for standard benefits including a full range of medical and dental benefits options, disability insurance, paid time off (inclusive of sick leave), other paid and unpaid leave options.

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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