What are the responsibilities and job description for the Technical Writer position at The HIRD?
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.
Salary : $69,750