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

Location: Thousand Oaks, California OR San Francisco, California OR Cambridge, Massachusetts

Employment Type: Contract

Business Unit: Digital Health & Diagnostics Quality

Duration: 12 months with likely extensions

Note: Remote until Covid restrictions are lifted.

3 Key Consulting is hiring a Principal Device Quality Engineer - IVD devices SME for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:

• Manager is open to candidates working remotely until restrictions are lifted.
• Candidates must have 5+ years working with IVD devices and be an IVD subject matter expert.
• This key role in the Quality organization will assist with the co-development, commercialization, and lifecycle management for diagnostic and companion diagnostic devices (IVDs) 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.
• Activities include 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.

Such devices may include (but are not limited to):

• IVDs intended to diagnose a condition client’s therapeutics treat
• IVDs intended for client drug titration
• IVDs intended to monitor a condition client’s therapeutics treat

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.

Top Must have Skill Sets:

• 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.

Employee Value Proposition:

• Compelling, active and growing area of interest and innovation within precision medicine.
• Ability to gain experience from the “pharma” side of IVD and companion diagnostics.
• Broad exposure to many innovative IVD manufacturers.

Red Flags:

• No or minimal practical experience for IVD manufacturers.
• “Consultant” view, rather than “executor” view. We need people to do actual work, not give advice on policy and strategy.
• Poor communicator.

Interview Process:

• Initial phone screen followed by 3 or 4 behavioral interviews (combined, 1 day).

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.