About Us
UniQ focuses on providing innovative immunoassay solutions for various challenges in rapid testing. With our Flow technology, UniQ is working to bring the next-generation rapid tests to life.
The ideal candidate will effectively be conducting experiments for research projects and developing new product lines and working collaboratively with other QA/RA talents on a daily basis. This is an entry level position
Some specific duties and tasks include, but are not limited to, the following:
· Responsible for independently conducting experiments for research project and developing new product lines of IVD medical devices
· Responsible for drafting and coordinating the submissions of product regulatory registration. Communications with Health Canada/FDA/CE
· Deliver internal and external quality assurance scientific and technical SOPs to meet ISO 13485 requirements
· Troubleshoot and resolve complex scientific and technical investigations
· Generate intellectual property and assist in writing patent applications. Perform literature and patent searches to identify new technologies and scientific trends. Identify and execute product and process improvement projects
· Prepare preliminary design specifications and draft design verification and validation test plans documentation
· Execute design verification and validation test plans as required
· Design and execute required stability studies
· Initiate and maintain design history files during early phases of product development
· Participate in risk management activities related with the product under development
· Generate technical documentation and provide pre-and post-product launch support
· Goal focused products and special assignments, including all admin/office jobs
What you will need to be successful:
· Bachelor or Master degree in a life sciences discipline (preferably biochemistry, microbiology, biology, biotechnology or related science)
· A minimum of 1 - 2 years’ experience in a medical device industry environment
· Strong technical knowledge on immunoassay, IVD test design, development, rapid test
. Knowledges of medical devices QA/RA requirements
· Skilled presenter to deliver technical summaries of data with critical thinking skills to provide in-depth analytical explanations and interpretations
· Ability to work in a dynamic and fast-paced team environment
Job Type: Full-time
Pay: $45,000.00-$50,000.00 per year
Schedule:
Application question(s):
- What is you expected salary range?
Work Location: In person
Job Type: Full-time
Pay: $48,000.00-$50,000.00 per year
Shift:
Work days:
Education:
- Bachelor's Degree (required)
Experience:
- Presentation skills: 1 year (required)
Work Location: In person
