Specialist II Quality Assurance (Onsite)

Responsibilities

• 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.
• 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.
• Support product and raw material testing, regulatory submissions, equipment maintenance, oversight of all laboratory calibrated items, documentation, and cross-functional quality initiatives.
• 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.
• 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.
• Develop, execute, review, and support equipment, software, and test method validations for laboratory equipment and processes.
• 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.

Qualifications

• 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.
• Experience in the medical device industry, product testing knowledge would be an asset.
• 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.