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- Los Angeles, CA
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Principal Quality Engineer
Astrix Technology Group • Los Angeles, CA
Posted 6 days ago
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Title: Principal Quality Engineer
Contract Duration: 12 - 36 months (potential extension or permanent conversion)
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 therapeutics' team. 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.
- 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.
• IVDs intended to diagnose a condition Amgen’s therapeutics treat
• IVDs intended for Amgen drug titration
• IVDs intended to monitor a condition Amgen’s 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.
- 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
- Experience with audits, quality inspections, and quality agreements such as purchasing controls.
- Quality/Technical experience within GMP regulated IVD manufacturer (IVDD, IVDR, FDA QSR).
- Ability to teach IVD experience to a high-performing staff with only device quality background.
- 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.