Specialist II Quality Assurance (Onsite)

Cordis•Miami Lakes, FL

20h•Onsite

About The Position

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care. At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients. If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you. We are the people behind the people who keep saving lives.

Requirements

Requires a minimum 3+ years of relevant experience with a Bachelor's degree; or equivalent education and experience; Or an advanced degree with no previous professional experience.
Where required, the role must hold an appropriate degree in the industry (eg. Legal)

Nice To Haves

In-depth knowledge of Instron Material Testing Machines
Technical understanding of mechanical and physical testing
Experience with Particulate product testing
Understanding of cardiology medical devices and accessories
Experience setting up simulated use fixtures
Experience with Environmental Chambers shelf-life studies, accelerated aging, simulated sterilization and other custom temperature or humidity studies
Understanding the science of accelerated aging
Experience managing laboratory equipment calibration items, preventive maintenance, maintenance schedules, and equipment records
Experience developing, executing, reviewing, and supporting equipment, software, and test method validations
Experience operating, maintaining, and troubleshooting laboratory equipment and major components
Experience interacting with outside vendors for troubleshooting or setting up equipment and/or service
Experience preparing technical reports and documentation
Experience reviewing, creating, approving, and maintaining procedures, work instructions, forms, records, and other controlled documentation
Experience investigating, assisting with the design and purchase of laboratory equipment
Experience providing guidance, training, and technical direction to lower-level laboratory, engineering, or technical associates
Working knowledge of applicable standards and regulatory requirements, including GMP, ISO, ASTM, and standards related to the laboratory testing environment.

Responsibilities

Reports to the Quality Analytical Laboratory Manager.
Performs complex assignments requiring sound judgment, initiative, problem solving, and technical recommendations.
Conducts laboratory testing and investigations using established methodology.
Supports development of new or improved methods.
Applies specialized mechanical, electrical, air-conditioning, and refrigeration knowledge to maintain laboratory equipment in proper working condition.
Supports product and raw material testing, regulatory submissions, equipment maintenance, oversight of all laboratory calibrated items, documentation, and cross-functional quality initiatives.
Demonstrates expertise in assigned analytical and product testing activities and provide technical input regarding the impact of test results on products, raw materials, components, prototypes, or finished devices.
Demonstrates technical understanding of mechanical and physical testing, specifically with Instron Material Testing Machines.
Leads Particulate product testing to support regulatory submissions, new product introductions, demonstrating understanding of cardiology medical devices and accessories as well as set up of simulated use fixtures to support testing.
Performs laboratory testing for receiving inspection, new vendor evaluation, characterization and manufacturing support.
Collaborates with New Product Development, R&D, Quality, Engineering, Manufacturing, Global IT, Software Quality Compliance, and other relevant functions to support testing needs, new tool designs, laboratory systems, and corrective actions.
Manages Environmental Chambers shelf-life studies, accelerated aging, simulated sterilization and other custom temperature or humidity studies; understanding the science of accelerated aging, the chamber equipment, state in which the product/material should be tested and demonstrates a quality discipline to manage the evidence to support the project.
Demonstrates technical understanding of environmental chambers to manage risk, recognize abnormal behavior, document issues correctly, and involve the right specialists when needed.
Manages laboratory equipment calibration items, preventive maintenance, maintenance schedules, and equipment records based on manufacturer recommendations and company requirements.
Develops, executes, reviews, and supports equipment, software, and test method validations for laboratory equipment and processes.
Operates, maintains, and troubleshoots laboratory equipment and major components; following standard operating procedures for all applicable tasks which may include interaction with outside vendors for troubleshooting or setting up equipment and/or service.
Performs complex tests, analyses, calculations, inspections, and documentation activities to verify that products and materials comply with established specifications.
Prepares technical reports and documentation to summarize testing, investigations, results, findings, recommendations, acceptance, rejection, and disposition as applicable.
Reviews, creates, approves, and maintains procedures, work instructions, forms, records, and other controlled documentation related to laboratory activities.
Investigates, assists with the design and purchase of laboratory equipment that meets testing requirements and applicable health, safety, environmental, and quality standards.
Recommends and implements revisions, corrections, and changes to test equipment, procedures, methods, and documentation to improve compliance, efficiency, and reliability.
Provides guidance, training, and technical direction to lower-level laboratory, engineering, or technical associates as needed.
Develops working knowledge of applicable standards and regulatory requirements, including GMP, ISO, ASTM, and standards related to the laboratory testing environment.