Senior Quality Engineer – Microbiology

1 week ago


Bengaluru, Karnataka, India ALTEN India Full time

JOB DESCRIPTION:

Essential duties & responsibilities:

Possess knowledge of a variety of microbiological concepts, practices, and procedures related toFDA guidelines, EU guidelines, ISO17664, ISO 17665, AAMI ST79, ANSI/AAMI ST98, AAMI TIR 12and ISO Manage the testing conducted by external laboratories according to procedures and standardsregarding reprocessing activities (cleaning and sterilization) and biocompatibility Complete document of external origin gap assessments as needed for reprocessing activities(cleaning and sterilization) and biocompatibility Maximize the biocompatibility of products using industry guidelines and advanced testingtechnologies Review and approve microbiological testing data ensuring compliance to the applicable methods and regulatory standard requirements May support in the development, review and approval of sterilization process and equipmentvalidation/qualifications (IQ, OQ & PQ).

Support product transfers to other plants/facilities. Review/approve nonconforming material and system documentation. Review/approve product and process change control documentation and specifications. Support design verification and validation test requirements that ensure appropriate objectiveevidence is available to support acceptance criteria.

Participate in design reviews by identifying risks associated with the product use and tracking how thedesign, documentation, and manufacturing process mitigate those issues throughout thedevelopment process.

Implement data analysis and statistical techniques to drive appropriate risk management activitiesand prioritization of issues.

Ensure effective implementation and compliance to all applicable regulations and standards, including21CFR820, ISO 13485, ISO 14971 throughout the design and development process.


Education & special trainings:
M

Sc in Microbiology Experience:
Min 10 years of experience in applied device or pharmaceutical microbiological orbiological testing, research and development, or sterility assurance experience

Qualifications & experience:

Must understand the fundamentals of at least one of the following sterilization techniques: gamma irradiation, ethylene oxide (preferred), hydrogen peroxide gas plasma, moist heat, or dry heat and be an expert in one of the techniques.

Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures.

Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design,manufacturing, development, and launch of initiatives.

Experience with ISO 17025, Lab Quality Management System. Ability to effectively work cross-functionally with Product Development, Operations and

Marketing. Must understand the fundamentals of moist heat, gamma irradiation, and ethylene oxide sterilization. Prefer experience with medical device product development lifecycle, including risk management anddesign/process verification and validation.

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