Title: Technical Writer -Medical Devices
Here we grow again!!!!
Wipro is 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.
"Although this role will be onsite in Pittsburgh, PA you must live within 100 miles of the Wipro/Client’s office location in Pittsburgh, PA to facilitate training, corporate services and other in-person requirements of the role.” Mandatory Skills: Technical Writing, CAD and Visio. Experience: minimum of 2 years. Expected annual pay for this role ranges from $60,000 to $67,000 . Must be able to work in the USA without future sponsorship or letter(s).Based on the position, the role is also eligible for Wipro’s 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.Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome.
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.
Nearest Major Market: Pittsburgh