Specialist II Quality Assurance (Onsite)

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.

The Specialist II Quality Assurance - QA Analytical Lab reports to the Quality Analytical Laboratory Manager. Under general supervision and, at times, independently, this role performs complex assignments requiring sound judgment, initiative, problem solving, and technical recommendations. The position conducts laboratory testing and investigations using established methodology, supports development of new or improved methods, and applies specialized mechanical, electrical, air-conditioning, and refrigeration knowledge to maintain laboratory equipment in proper working condition. The role also supports product and raw material testing, regulatory submissions, equipment maintenance, oversight of all laboratory calibrated items, documentation, and cross-functional quality initiatives.

Includes the following at a minimum.  Other duties may be assigned depending on the business needs:

• Demonstrate 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.
• In-dept knowledge of Instron Material Testing Machines, demonstrate technical understanding of mechanical and physical testing
• Lead 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
• Perform laboratory testing for receiving inspection, new vendor evaluation, characterization and manufacturing support.
• Collaborate 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.
• Manage 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.
• Demonstrate technical understanding of environmental chambers to manage risk, recognize abnormal behavior, document issues correctly, and involve the right specialists when needed.
• Manage laboratory equipment calibration items, preventive maintenance, maintenance schedules, and equipment records based on manufacturer recommendations and company requirements.
• Develop, execute, review, and support equipment, software, and test method validations for laboratory equipment and processes.
• Operate, maintain, and troubleshoot 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.
• Perform complex tests, analyses, calculations, inspections, and documentation activities to verify that products and materials comply with established specifications.
• Prepare technical reports and documentation to summarize testing, investigations, results, findings, recommendations, acceptance, rejection, and disposition as applicable.
• Review, create, approve, and maintain procedures, work instructions, forms, records, and other controlled documentation related to laboratory activities.
• Investigate, assist with the design and purchase of laboratory equipment that meets testing requirements and applicable health, safety, environmental, and quality standards.
• Recommend and implement revisions, corrections, and changes to test equipment, procedures, methods, and documentation to improve compliance, efficiency, and reliability.
• Provide guidance, training, and technical direction to lower-level laboratory, engineering, or technical associates as needed.
• Develop working knowledge of applicable standards and regulatory requirements, including GMP, ISO, ASTM, and standards related to the laboratory testing environment.

Required Qualifications

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)

• Experience in the medical device industry, product testing knowledge would be an asset.
• Must be hands-on, comfortable working in a laboratory setting performing various tasks
• Self-starter, ability to take initiative to troubleshoot or recommend mechanical or electrical improvements to the laboratory equipment.
• Ability to use the most sophisticated test and measurement equipment associated with specific discipline.
• Ability to read and understand complex technical documentation associated with specific discipline, including drawings.
• Excellent communication, presentation and technical writing skills.
• In-depth ability to use PC's and associated sophisticated software.
• Thorough knowledge of company and related products.
• Ability to read, write, communicate and understand English.
• Successful completion of company and department training courses in the related discipline.
• Familiarity with applicable regulatory requirements and standards, including GMP, ISO, ASTM, and related laboratory requirements.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.  Laboratory work may involve moving mechanical parts, airborne particles, chemicals, and risk of electrical shock. The employee must wear required proper protective equipment in laboratory areas, regularly stand, and occasionally lift or move up to 25 pounds. The noise level is quiet to moderate.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammate's points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.