Santa Clara, CA, 95054, USA
7 hours ago
Quality Training Coordinator I - Shockwave Medical
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Quality Documentation **Job Category:** Business Enablement/Support **All Job Posting Locations:** Santa Clara, California, United States of America **Job Description:** Johnson & Johnson is hiring for a **Quality Training Coordinator – Shockwave Medica** l to join our team located in **Santa Clara, CA.** Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. **Position Overview** The Quality Training Coordinator is responsible for managing and maintaining Shockwave Medical’s Quality Management System training program in accordance with FDA, European MDD/MDR, and ISO regulations. This position works with all levels of the organization and requires excellent written and verbal communication. Must be able to organize and process training records in both paper and electronic formats. **Essential Job Functions** + Coordinate with hiring managers to setup training sets for new hires that may include technical and Quality Management System procedures + Work with Manufacturing to maintain Direct Labor training and certification records + Work with department heads to review and maintain minimum training requirements by function and title (Training Plans) + Manage training tasks for employees on extended leave + Mentor and train employees on how to use the QMS training system + Monitor and send out past due training notifications + Maintain and prepare training metrics to present at Management Review + Ensure suppliers are properly trained to applicable procedures before coming on-site to perform work + Maintain hard copy training records and send to off-site storage for archiving as needed + Identify and drive improvements to the Training process + Support and perform Document Control duties as backup as required + Support Internal audits and third-party audits from regulatory agencies as the subject matter expert on the Training System + Other duties as assigned. **An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.** **Requirements** + Bachelor’s Degree preferred with 2 years of experience, or a high school diploma and 4+ years of experience as a Training Coordinator or Document Control Coordinator in a manufacturing environment + Experience working in the medical devices industry is preferred + Practical knowledge of cGMP requirements + Working knowledge of MS word, excel and other database systems. Knowledge of Solid Works or other draw programs preferred + Ability to work in a fast-paced environment while managing multiple priorities + Must have strong written and verbal skills, and be able to effectively communicate with all levels of the organization + Must be self-motivated and proactive + High attention to detail and the ability to prioritize work in an effective manner + Operate as a team and/or independently while demonstrating flexibility to changing requirements. _Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act._ _Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via_ _https://www.jnj.com/contact-us/careers_ _or contact AskGS to be directed to your accommodation resource._ **The anticipated base pay range for this position is :** $47,150 - $75,383 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
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