Job title: Validation Qualification Engineer – Lab
Company: Stryker
Job description: Why engineering at Stryker? At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker,you will be proud of the work that you will be doing, using cutting-edge
Why engineering at Stryker At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker,you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better.Here,you will work in a supportive culture withotherincredibly talented and intelligentpeople, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development. Need another reason to apply Check out these 8 reasons to join Stryker’s engineering team: Who we want: Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate Data managers . People who enjoy compiling, organizing and consolidating large volumes of data and reports. Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations. Meticulous documenters . Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. Self-directed imitators . People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. What you will do: Prepare SOPs, protocols, perform qualification and validation of lab equipment (s)/ methods. Discuss with team members/ equipment (s) owner to understand the qualification/ validation requirement. Understand, plan and qualify the equipment(s)/ methods as per the schedule requirement discussed with team. SME/ stakeholder’s meetings and use of validation software to document qualifications and to maintain it. General use handling of lab equipment (s) viz. LAF, BSC, autoclave, device washer, spectrophotometer, ultrasonic and hot/cold bath, incubators, Instrons/ UTMs, Fixture designed for testing, other mechanical instruments, and equipment qualifications for the same. Support team members to create or improve procedures, policies, processes, systems, and technology requirements. Deliver high quality results with passion, energy, and drive to meet business priorities. What you need: Working area experience in equipment qualification/ method validation activities in Pharma/ medical devices industry with a minimum of 5+ Years of Experience. Knowledge of USFDA, ANVISA, EU and other regulatory bodies requirement for equipment qualification/ method validation Working knowledge of EQ/ AMV/ PV/ CSV/ MSA/ PSP/ Stats analysis where required etc. knowledge of any LIMS/ software documentation system. Knowledge/Understanding and ability to use – different standards like AAMI, USP, ANSI, EPA, EU ISO 13485, ISO 17025, Quality Management Systems for Medical Devices 21 CRF 820 and GMP. Strong experience QMS and Risk Analysis tools & techniques. Understanding on Medical Device Development Life Cycle process and testing will be given weightage Understanding of various documentation required for testing. Good communication and team skills Know someone at Stryker Be sure to have them submit you as a referralprior to applyingfor this position. Learn more about ouremployee referral programat About Stryker Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting
Expected salary:
Location: Gurgaon, Haryana
Job date: Fri, 11 Feb 2022 23:10:36 GMT
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