Principal Device Quality Engineer - IVD devices SME (JP9691)

🚀 About the Role

3 Key Consulting is seeking a Principal Device Quality Engineer with expertise in In Vitro Diagnostic (IVD) devices for a contract position with a leading global biopharmaceutical company. This is a highly visible role, working with cross-functional teams and IVD manufacturers on co-development, commercialization, and lifecycle management of diagnostic and companion diagnostic devices. Initially remote until COVID restrictions are lifted. The position reports to the Device Quality department leadership team in Thousand Oaks, CA.

🎯 Responsibilities

• Assist with the co-development, commercialization, and lifecycle management of IVD devices.
• Conduct manufacturer due diligence, evaluations, and audits.
• Ensure compliance with regulations and standards (21 CFR 820, European Medical Device Directives (MDD) and Regulations (MDR), IEC 62304, ISO 13485, ISO 14971, IEC 62366).
• Manage design controls, inspection readiness, and lifecycle management.
• Provide quality leadership for regulatory interactions.
• Review and approve procedures and work instructions.
• Employ quality principles across Purchasing Controls, Design Controls, Change Controls, NC/CAPA, Risk Management, Human Factor Engineering, Process Validation, and Manufacturing and Distribution.
• Train and educate functional partners and management on IVD requirements, standards, and regulations.
• Suggest and participate in quality system improvements.

💪 Required Skills and Experience

• Minimum Qualifications: Doctorate degree and 2 years of experience OR Master’s degree and 6 years of experience OR Bachelor’s degree and 8 years of experience OR Associate’s degree and 10 years of experience OR High school diploma/GED and 12 years of experience. All experience must be directly related.
• Preferred Qualifications: BS in Science/Engineering (chemistry, biology, software, mechanical, or electrical engineering preferred).
• 5+ years of Quality, Engineering, or Operations experience in the IVD medical device industry.
• Experience with quality systems (21 CFR 820, MDD/MDR, IEC 62304, ISO 13485, ISO 14971, IEC 62366).
• Knowledge of Medical Device Design Controls, especially for in vitro devices.
• Strong project management skills.
• Excellent cross-functional team collaboration and influencing skills.
• High integrity, positive attitude, and strong work ethic.
• Ability to work independently and with remote colleagues.
• Excellent communication and teaching skills.

➕ 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 train high-performing staff with device quality backgrounds (but not necessarily IVD experience).

💼 Location & Work Arrangement:

Thousand Oaks, CA; San Francisco, CA; or Cambridge, MA. Remote work until COVID restrictions are lifted.

🌟 Benefits & Perks:

• Work in a compelling, active, and growing area of precision medicine.
• Gain experience from the "pharma" side of IVD and companion diagnostics.
• Broad exposure to innovative IVD manufacturers.

🚩 Red Flags:

• Minimal practical experience with IVD manufacturers.
• Consultant mindset instead of an executor mindset.
• Poor communication skills.

🗓️ Interview Process:

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

➡️ Apply Now:

Send your resume to resumes@3keyconsulting.com

🌐 Learn More:

Visit www.3keyconsulting.com for other opportunities. Feel free to share this posting!

(Optional) Company Summary:

3 Key Consulting partners with leading companies in the life sciences industry, providing expert consulting services. They value collaboration, innovation, and a commitment to excellence.

Job Category: Healthcare