Principal Device Quality Engineer - IVD devices SME (JP9691-C)

3 Key Consulting is hiring a Principal Device Quality Engineer for an unnamed direct client, a leading global biopharmaceutical company. The role supports co-development, commercialization, and lifecycle management of diagnostic and companion diagnostic IVD devices, providing quality leadership across manufacturer evaluation and audits, design controls, regulatory interactions, and inspection readiness.

Responsibilities:

• This key role in the Quality organization will assist with the co-development, commercialization, and lifecycle management for diagnostic and companion diagnostic devices (IVD’s) to support the client therapeutics
• The role will be highly visible, interacting with cross-functional internal European and U.S. management and technical team members, and multiple IVD manufacturers, to prepare for and execute activities including manufacturer due diligence and evaluation, manufacturer auditing, design control, inspection readiness and lifecycle management
• The position will report to a member of the Device Quality department leadership team and provide thought leadership and current best practices surrounding considerations and continued development of internal processes related to control of IVDs. The staff member will report to the Corporate Quality function at the Thousand Oaks, California headquarters
• 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
• Specifically, this role will 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

Requirements:

• Candidates must have 5+ years working with IVD devices
• Doctorate degree and 2 years of directly related experience
• Master's degree and 6 years of directly related experience
• Bachelor's degree and 8 years of directly related experience
• Associate's degree and 10 years of directly related experience
• High school diploma / GED and 12 years of directly related experience
• 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
• Audits / inspections / quality agreements (purchasing controls)
• Quality or Technical experience within a GMP regulated IVD manufacturer (IVDD, IVDR, FDA QSR)
• Ability to teach high performing staff who have a device quality background, but not necessarily IVD experience