This is Bhanu from Intellectt INC; we have an immediate opportunity with one of our clients. Please find the below job description and if you are interested, please forward your resume to bhanuprakash@intellectt.com
Role: Medical Device Technical Writer
Location: Austin, Texas (onsite only)
Duration: Long Term
Job Description
Mandatory Skills:
Minimum of 3 years of experience in an engineering or quality related position
Knowledge of Pharmaceutical/Medical device regulations of FDA - 21 CFR Part 11, 21 CFR Part 58, 21 CFR Part 210, 21 CFR Part 211 and 21 CFR Part 820
Implementation experience with Medical Device ISO13485 IQ, OQ, and PQ protocol development and execution
Ability to develop and execute standard operating procedures that could consist of, Testing Methods, Safety Methods, and Manufacturing Methods
Proficient in Microsoft Applications, word, excel etc
B.S in Engineering or Technical Practice.
Responsibilities
Provide support to the engineering and manufacturing, and quality functions within a team participation setting
Document and communicate the results of problem solutions and conduct analytical examinations to both internal and external customers
Responsible for implementing the document workflow process as a formal written procedure
Advocate the usage of quality improvement and control tools
Update and develop documents where required including technical manuals, instruction manuals, and other pertinent documents as part of an overall document plan to ISO 13485 requirements.
Desired Characteristics
Strong oral and written communication skills
Capability to work in teams
Six Sigma Green Belt Certified
QMS implementation experience
Manufacturing Experience with Medical Industry Components
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Marketing, Public Relations, and Writing/Editing
Industries
Human Resources Services
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