Set up and maintain the analytical chemistry equipment in the laboratory; Support development and manufacturing by performing sample analysis; and Contribute to regulatory approval by validating the equipment and processes.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Perform analytical and other wet-chemistry related tests.
Maintain HPLC and other laboratory equipment, including routine maintenance and up-keep.
Generate standards and formulations per procedures.
Conduct analysis of incoming materials, in-process, and finished product per procedures.
Perform QC testing to support the development, manufacture and release of products.
Conduct method validation activities in conjunction with laboratory staff for the purposes of regulatory approval.
Deliver timely, accurate and reliable results following good laboratory principles and established SOPs.
Compile data for documentation and prepare reports.
Conduct root cause analysis and OOT/OOS laboratory investigations when necessary.
Apply knowledge of Good Manufacturing Practices and Good laboratory Practices on a daily basis.
Other duties as assigned.
QUALIFICATIONS (EDUCATION, EXPERIENCE, SKILLS):
Bachelor of Science with a minimum of 2 years of experience in the medical device industry. Masters desired.
Proven track record in an analytical role. Must be an expert in HPLC and other laboratory equipment.
Demonstrated ability to work within a Quality System and follow all established procedures.
Bachelor's Degree, Post Graduate Diploma, Professional Degree
We specialize in the Design & Development, contract-manufacturing and larger-volume manufacturing of complex catheters, covering the range from μCatheters for neuro-applications to AAA systems.
From early development to market introduction
Concept Design & Development
Design for Manufacture
Pre-clinical & Pilot Manufacturing
Launch: Manufacturing ramp-up
Supply Chain Management
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