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Staff Quality Engineer - Biocompatibility & Sterilization
Imperative CareUnited Statesfull_timeVerifiedPosted 3 Jun 2025
💰 $161,000/yr($151,000/yr – $161,000/yr)
About the role
Title: Staff Quality Engineer – Biocompatibility & Sterilization
This position is based in our Campbell, California offices. This position is on-site, full-time.
Why Imperative Care?
Do you want to make a real impact on patients?
As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the needs of the patient, and they come first in everything we do.
What You’ll Do
The Staff Quality Engineer is the subject matter expert who establishes and or supports processes, protocols, methods, and techniques to ensure compliance with quality standards and regulatory requirements during the development, manufacture and distribution of our medical device products. This role will involve leading sterilization and microbiology activities and/or overseeing the work of more junior team members or contracted testing laboratories, depending on focus area.
- Hands on experience with deep knowledge in terminal sterilization modality (Ethylene Oxide preferred) and understands applicable ISO and guidance documents related to sterility assurance-Sterilization (ISO11135) , Microbiology (ISO 11737 series and ISO 11138 series), Cleanrooms (ISO 14644 series, ISO 14698, AAMI TIR 52) and Quality Systems (ISO 13485). And understanding of Biocompatibility (ISO 10993 series).
- Develop and execute quality plans and provide strategic input throughout the product development lifecycle to ensure products comply with regulatory and internal quality systems requirements. Share data analytics related to quality metrics with focus on Microbiology, Sterilization and Biocompatibility.
- Provides microbiological, sterilization and biocompatibility technical expertise during new product development activities, process modification studies and failure investigations regarding microbiological contamination control, impact to product and validated sterilization cycles. Serves as technical liaison with functional groups, contract laboratories and manufacturing sites.
- Support Risk Management Report process and contribute to the development of Use Risk, Design Risk and Process Risk documentation as it relates to Microbiology, Sterilization and Biocompatibility.
- Collaborate cross-functionally on pilot production of new products and improvement projects.
- Establish and maintain quality assurance procedures and educate peers on their use for Microbiology, Sterilization and Biocompatibility.
- Support management of relationships with suppliers and testing laboratories by supporting development of quality agreements, assessing performance, troubleshooting failures and creating corrective action plans.
- Participate in supplier qualification activities, including on-site audits and evaluations as it relates to Microbiology, Sterilization and Biocompatibility.
- When a position’s focus is microbiology, sterilization and biocompatibility, lead all activities and projects related to laboratory selection, compliance audits, along with testing analyses and results interpretation.
- Develop and implement sterilization protocols and procedures according to regulations.
- Plan and execute validation studies of sterilization and assessments and requalification activities.
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