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 **Document Control Specialist II** **– 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** In compliance with FDA, European MDD/MDR & ISO regulations, the Document Control Specialist II will perform work exercising judgment with only general supervision. General scope of this position is to maintain product related documentation and the flow of information in the form of controlled documents and engineering change orders, over the life cycle of any given product manufactured at SWMI. This position requires frequent use and general knowledge of industry practices, techniques, and standards. **Essential Job Functions** + Maintain the change control process via engineering change control system (log, track and process changes, maintain material item data, and BOM data) + Check revised documents and completed change orders to assure the highest level of accuracy and conformance with the approved format and standards + Review, process, and release documents using variety of software packages. + Maintain electronic files of master active or archived documents (native source application files as well as the .pdf viewable files) + Maintain controlled access to master files and archived documents on Shockwave Medical’s system and/or shared servers + Assist in the data entry of employee training records when needed + Assist maintenance of Direct Labor Competency Assessment Records when needed + Support Regulatory Assurance by assisting backroom activities during audits + May support periodic departmental audits to assure that the appropriate procedures are followed and that the highest levels of compliance are continually achieved + Assist in implementation of solutions to a variety of problems + Manage the review and approval of QMS changes. + Other duties as assigned. **An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.** **Requirements** + Bachelor’s Degree with a minimum of 2 years of experience, or a high school diploma and 4+ years of experience in document control in a manufacturing environment + Experience working in the medical device 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 + Operate as a team and/or independently while demonstrating flexibility to changing requirements + Employee may be required to lift objects up to 25lbs _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 :** $56,350 - $89,930 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