Chemist I - Laboratory Testing and Validation

About the role

Edwards' Quality teams help shape the development of medical device technologies to the highest standards of integrity and safety. As a Chemist I, you will use your scientific expertise to support chemistry testing activities and business outcomes, partnering with various teams to influence decisions for a product's entire lifecycle.

Key responsibilities

• Set parameters of complex laboratory instrumentation to perform receiving inspection, raw material, environmental control, in-process solution and final product release testing
• Investigate and perform corrective and preventative action (CAPA) testing
• Create and develop validation plans for laboratory equipment and methods, and write lab-specific protocols, reports and methods
• Take part in process improvement projects (e.g. BEST, Lean) and propose recommendations for manager approval
• Perform routine lab operations, including updating documents, and interpret data and run trend analysis
• Define qualification strategies for new or modified devices and processes, recommend and validate new laboratory equipment, and train, coach and guide lower-level employees

Required profile

• Bachelor's degree in Chemistry
• 2 years of experience in a chemistry environment
• Fluent English and Spanish
• Knowledge of Edwards policies, chemical principles, and Edwards EHS and quality guidelines for clean-room medical device manufacturing
• Ability to handle confidential information discreetly, work in a team, and manage competing priorities in a fast-paced environment

Required skills

• Good written and verbal communication and interpersonal skills
• Problem-solving and critical thinking
• Good knowledge of laboratory equipment such as gas chromatography, HPLC, TOC, FTIR and atomic absorption
• Knowledge of Good Manufacturing and Good Documentation Practices in a medical device environment
• Preferred: proven expertise in MS Office and analytical software such as ChemStation and Empower