Sr. Principal Device Quality Engineer

Description:

• Employ quality principles and company’s procedures including but not limited to the areas of Purchasing Controls, Design Controls, Change Controls and NC/CAPA, Risk Management, Human Factor Engineering, Process Validation, and Manufacturing and Distribution, to ensure co-development and sustainment of IVD products complies with applicable regulations and standards. Such devices may include (but are not limited to):
• IVDs intended to diagnose a condition therapeutics treat
• IVDs intended for drug titration
• IVDs intended to monitor a condition therapeutics treat
• Train and educate key functional partners and management on regional and international IVD requirements, standards and regulations
• Suggest and participate in improvements to the quality system, particularly related to IVDs
• Provide Quality leadership for regulatory interactions for IVDs
• Review and approve procedures and work Instructions

Basic Qualifications:

• Doctorate degree and 2 years of directly related experience OR
• Master’s degree and 6 years of directly related experience OR
• Bachelor’s degree and 8 years of directly related experience OR
• Associate’s degree and 10 years of directly related experience OR
• High school diploma / GED and 12 years of directly related experience

Preferred Qualifications:

• BS in Science/Engineering - preferably chemistry, biology, software, mechanical, or electrical engineering
• 5+ years of Quality, Engineering or Operations experience in the IVD medical device industry
• Experience with quality systems including: 21 CFR 820, European Medical Device Directives (MDD) and Medical Device Regulations (MDR), IEC 62304, ISO 13485, ISO 14971, IEC 62366.
• Knowledge of Medical Device Design Controls, particularly for in vitro devices. Experience working in in vitro device development, manufacturing or validation function is a plus.
• Experience with designing and executing IVD clinical trials is a plus, particularly as part of a co-development agreement between a biopharmaceutical manufacturer and an IVD manufacturer
• Experience in interacting with notified bodies and regulatory agencies in an inspection setting for In Vitro devices.
• Strong project management skills including the ability to manage multiple workflows simultaneously and work within business processes as well as quality management systems
• Ability to work in a cross-functional team environment and to influence personnel across functions and at all levels
• High personal integrity with a positive attitude and a strong work ethic
• Experience in driving improvement and implementing change
• Demonstrated the ability to effectively work independently and with individuals located in remote locations
• Inter-personal skills and demonstrated ability to teach lay staff quality principles