Operations Training Specialist

Company: Johnson & Johnson
Location: Irvine
Posted on: May 15, 2022

Job Description:

Biosense Webster Inc., a part of the Johnson & Johnson family of companies, is currently hiring for an Operations Training Specialist located in Irvine, CA.At Biosense Webster, Inc. we have one goal - to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes.Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we've been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day.Learn more about Biosense Webster at and follow us on LinkedIn.The Operations Training Specialist will be responsible for organizing, supporting, and conducting training for operations associates in addition to executing certification processes for catheter manufacturing lines in a cleanroom environment.Key Responsibilities:Ensure quality and safety compliance of cleanroom operations. Maintain compliance with GMP, ISO, SOP, and safety guidelines.Lead individual and large-group training on manufacturing procedures, quality and compliance standards, and documentation requirements.Support development of materials for orientation, process training, safety, and compliance.Review and verify documentation such as device history and training records per GDP and GMP requirements. Maintain audit readiness for manufacturing documentation.Ensure all work order execution procedures are followed, and any gaps get communicated and documented in a timely and compliant manner.Supervise training adherence and update trackers to supervise progress. Ensure compliance training metrics are met.Plan and track material/tooling requests to meet weekly build plans and timelines. Collaborate with line leads to ensure compliance with materials traceability and organization.Assist in compiling reports on training and operational activities. Connect with team and cross-functional partners to provide daily, weekly and quarterly updates.As needed, support activities related to prototyping, process validation, or equipment qualification including development of process instructions, documentation reviews, and operational logistics.As needed, assist with refining existing processes, systems, and equipment. Collaborate with engineers and technicians to optimize the operational efficiency of cleanroom activities.QualificationsQualifications:High school diploma or general education degree (GED) is required. Technical/vocational certificate or associate degree is preferred.Prefer 2+ years of experience in small component or medical device research and development, and manufacturing.Ability to understand and explain technical documents, operating and maintenance instructions, and procedure manuals.Ability to work in large teams and communicate effectively.Proficiency in basic computer skills (including Microsoft Outlook, Word, and Excel).Ability to work in a regulated environment in compliance with ISO 13485 and 21 CFR 820 is requiredWork Environment and Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.The employee is regularly required to talk or hear while performing the duties of this jobThe employee is frequently required to stand, walk; use hands to finger, handle, or feel; and reach and hands and arms.The employee will be required to wear special garments (PPE) when working in the cleanroom environmentThe employee will be working will be using microscopes or close vision to perform his/her duties, as neededAt Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .Primary LocationUnited States-California-Irvine-31 Technology DrOrganizationBiosense Webster Inc. (6010)Job FunctionOperationsRequisition IDW

Keywords: Johnson & Johnson, Irvine , Operations Training Specialist, Other , Irvine, California