Senior Quality Engineer – Microbiology

3 weeks ago

Bengaluru, India ALTEN India Full time

JOB DESCRIPTION:


Essential duties & responsibilities:

▪ Possess knowledge of a variety of microbiological concepts, practices, and procedures related to

FDA guidelines, EU guidelines, ISO17664, ISO 17665, AAMI ST79, ANSI/AAMI ST98, AAMI TIR 12

and ISO 10993.

▪ Manage the testing conducted by external laboratories according to procedures and standards

regarding 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 testing

technologies

▪ 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 equipment

validation/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 objective

evidence is available to support acceptance criteria.

▪ Participate in design reviews by identifying risks associated with the product use and tracking how the

design, documentation, and manufacturing process mitigate those issues throughout the

development process.

▪ Implement data analysis and statistical techniques to drive appropriate risk management activities

and prioritization of issues.

▪ Ensure effective implementation and compliance to all applicable regulations and standards, including

21CFR820, 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 or

biological 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 and

design/process verification and validation.

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