Participate in a Quality Management Systems Program, with the primary responsibility being the creation of high-quality written content to support regulatory submissions.
Daily interaction with technical documentation, documentation tasks to be performed with high throughput and attention to detail
Required to proofread, prepare, create, review, edit, and/or update Quality and Technical Documents including, but not limited to: SOPs, Design Control Documentation (Design and Development Plan, Customer Requirements, Product Requirements, Design Outputs, Design Verification Protocol and Reports), Technical Reports, Risk Management Documentation including FMEAs
Understands and is aware of the quality consequences which may occur from the improper product performance; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing, and testing activities
May have supervisor duties for small teams and may direct staff in their day to day work and assist in problem solving.
Demonstrate technical proficiency in general laboratory techniques
Conduct experiments of a varied nature in support of on-market products
Works with a multidisciplinary team including other scientists, researchers, and technicians.
Analyze experimental results and provide written reports and oral presentations to executives
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships
Carries out duties in compliance with established business policies
Adapt rapidly to a changing industry and be able to adjust responsibilities, time and objectives accordingly
Perform other duties & projects as assigned
Basic Qualifications
Bachelor's degree in Biology, Biochemistry or Chemistry, or related technical field
Minimum of 5+ years of progressively responsible positions in a research development environment with laboratory and technical writing experience working under design control and developing human in vitro diagnostic tests for commercialization in the U.S and OUS
Ability to work as part of a team with excellent communication skills
Problem-solving skills combined with analytical skills and attention to detail
Experience owning the end-to-end documentation creating process
Proficiency with Microsoft Office, specifically in Word, Excel, and PowerPoint
Must be able to productively generate quality documentation to meet program timelines
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Other
Industries
Staffing and Recruiting
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