Santa Clara, CA, 95054, USA
1 day ago
Quality Asset Technician I
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 Control **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 Asset Technician I – Shockwave Medica** l to join our team located in **Santa Clara, CA.** 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/. 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** This entry-level position shall perform routine administrative tasks associated with asset and equipment management. The Quality Asset Technician I collaborates and assists the Staff Calibration Engineering Specialist with reviewing, scanning, and filing of equipment documentation. This person will be responsible for maintaining calibration, preventive maintenance, qualification, repair, and other asset management documentation for inspection, measurement, and test equipment. This position will be responsible for ensuring that all Shockwave equipment is properly labeled to maintain Identification and Traceability. This person will assist in ensuring calibration and preventive maintenance activities related to asset management are completed on time. **Essential Job Functions** + Support activities associated the Computerized Maintenance Management System (eMaint). + Maintain equipment documentation, including filing, scanning, and data entry. + Support equipment calibration activities as needed + Review equipment records, equipment histories, asset record data, and similar information for accuracy and completeness. Makes GDP corrections to assure data quality. + Perform QA related data entry into equipment logs and/or the eMaint system. + Support company goals, objectives, policies, and procedures in order to comply with FDA, ISO 13485, ISO 14001, and other applicable regulatory standards related to the medical device industry. + Interface and communicate effectively with cross-functional teams. + Read and understand quality documentation and specifications with minimal assistance. + Maintain ID and Traceability of equipment and maintain equipment/tool files as needed. + Other duties as assigned. **Requirements** + High school diploma with a minimum of 1 year of experience in Quality Assurance, Quality Control, or other equivalent experience in a medical device environment + Experience with equipment calibration and asset management is highly preferred + Must be able to work in a Class 100,000 (ISO Class 8) controlled environment room (CER) + Ability to understand and follow Quality Management System Procedures (e.g., SOP and Test Methods) + Understanding of cGMP, GDP, FDA QSR, and ISO13485 requirements is highly preferred + Experience with computer-based applications (MS Suite) + Excellent written and verbal communication skills + Experience and understanding of electronics/electrical systems is preferred + Understanding medical device manufacturing and medical device manufacturing environment is preferred + Experience with Medical Device Production Equipment is highly preferred + Experience with calibration certificates or asset management documents is preferred + Ability to work in a fast-paced environment while managing multiple tasks + Operate as a team and/or independently while demonstrating flexibility + May occasionally be required to lift objects up to 25 lbs. **An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.** **Pay Transparency:** + The anticipated pay range for this position is $18.70 - $33.17. + The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. + Employees and/or eligible dependents may be 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. + Employees may be 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. + Employees are eligible for the following time off benefits: + Vacation – up to 120 hours per calendar year + Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year + Holiday pay, including Floating Holidays – up to 13 days per calendar year + Work, Personal and Family Time - up to 40 hours per calendar year + Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits _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 and 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 email the Employee Health Support Center_ _(ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource._ **The anticipated base pay range for this position is :** $18.70 - $33.17 Additional Description for Pay Transparency:
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