Job Description

Are you interested in working for a global company where you can work across functions and on awide-varietyof projects As a member of Stryker\'s RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World\'s Best Workplaces, apply now ! Need another reason to apply Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team:https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team What you will do: Responsible for handling of microbiology lab & simulated reprocessing (cleaning and sterilization -instruments life test ) projects. Perform qualification and validation of microbiological methods and equipment (s). Cleaning disinfectant and sterilization validation of medical devices/Pharmaceutical product. Performs BI (Biological Indicator), Microbial limit test, growth promotion testing, environment monitoring, water testing and other general microbiological tests required for incoming, intermediate and finish sterile products/ medical devices. Apply GLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to sterilization, cleaning, disinfection, bioburden, bacterial endotoxin, of medical devices/ pharma products. Support team members to create or improve procedures, policies, processes, systems, and technology requirements. Independently lead and timely execution of complete project deliverables. Hold self-accountable to deliver on tasks & meet business deadlines. Mentor, influence and Support team on design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria. Implement data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues. Audits/ NC CAPA/ Deviations/ change control/ Procedures improvements/ risk evaluations and data/ record/ report reviews. Well versed in Pharma/ medical devices QMS. Assess new and or required test technologies and capabilities for the organization. Deliver high quality results with passion, energy, and drive to meet business priorities. Mentor, develop and influence across the business, intentionally building divisional relationships. What you need: Educational Degree of M.Sc./ B tech/ M tech - in Microbiology, Biotechnology, Bioengineering. Total Work Experience of 9-12 years with Min 7 years of experience in applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience. Strong Instrument Working Knowledge used in microbiology and analytical laboratories. Good to have in-depth knowledge of the industry and competitive landscape, ensure effective implementation, and compliance to all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 17025, ISO 14971 throughout the design and development process various test requirements. Worked with different regulatory bodies (USFDA, EU, PMDA, MHRA etc) in production requirements of medical devices/pharma etc. 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. Moist heat is preferred. Ability to use different standards like ISO, AAMI, USP, ANSI, EPA, EU for testing and related guidelines toward the design, manufacturing, development, and launch of initiatives in medical/ pharma. Ability to effectively work cross-functionally with Product Development, Operations and Marketing. Demonstrated organizational and written/verbal communication skills. About Stryker Stryker is one of the world\'s leading medical technology companies and, together with our customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually. More information is available at

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