Principal Device Quality Engineer - IVD devices SME JP9691-C
Principal Device Quality Engineer - IVD devices SME JP9691-C
Posted on :
11-04-2025
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Job Description
Job Title: Principal Device Quality Engineer IVD devices SMEJP9691
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
Job posting date: 1/20/2022
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 biopharmaceutical company.
Job Summary:
- Manager is open to candidates working remotely until restrictions are lifted
- Candidates must have 5 years working with IVD devices. Must be IVD subject matter expert.
- This key role in the Quality organization will assist with the codevelopment commercialization and lifecycle management for diagnostic and companion diagnostic devices (IVDs) to support the client therapeutics.
- The role will be highly visible interacting with crossfunctional 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 companys 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 codevelopment 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 clients therapeutics treat
- IVDs intended for client drug titration
- IVDs intended to monitor a condition clients therapeutics treat
Basic Qualifications
- Doctorate degree and 2 years of directly related experience OR
- Masters degree and 6 years of directly related experience OR
- Bachelors degree and 8 years of directly related experience OR
- Associates 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 codevelopment 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 crossfunctional 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
- Interpersonal 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 sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at other positions on our websitewww.3keyconsulting. You are welcome to also sharethis posting withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Required Experience:
Staff IC
Employment Type
Full Time
Key Skills
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