Johnson & Johnson
Quality Technician II - Shockwave Medical
Johnson & Johnson, Santa Clara, California, us, 95053
Overview
Johnson & Johnson believes 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. 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 Technician II Shockwave Medical
to join our team located in
Santa Clara, CA . Fueled by innovation at the intersection of biology and technology, were developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team thats 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 Technician II provides support to the Design Quality Engineering (DQE) team in daily activities. This role involves reviewing inspection and test data for adherence to Good Documentation Practices (GDP). The Quality Technician II must also be able to perform inspections and testing using various measurement systems. Essential Job Functions
Review test and inspection data to ensure compliance with Good Documentation Practices (GDP). Audit data collection processes for GDP compliance. Perform basic calculations and data analysis. Perform Document Change Orders for continuous improvement, or update according to GDP requirements: Data collection forms, Procedures, and Test Methods Review test data for accuracy when transferred/transcribed from data collection forms to any statistical or calculation software files for analysis. Review inspection and testing reports in accordance with Current Good Manufacturing Practices (cGMP) and maintain inspection and testing files as per established procedures. Perform inspection and functional testing of medical device components, tools & fixtures, subassemblies, and finished goods using various measurement systems (e.g., Scienscope, laser micrometer, pin gauges, height gauges, optical instrumentation, Instron, calipers, snap/drop gauges, balloon burst tester, etc.) per specifications or test protocols, and generate Non-Conformance Reports (NCRs) as necessary. Conduct functional testing of components, assemblies, and finished products according to required specifications or test protocols. Support company goals, objectives, policies, procedures, Quality System Regulations (QSR), and FDA regulations. Interface and communicate effectively with cross-functional project team members. Perform other duties as assigned. Requirements
High school diploma with a minimum of 2 years of experience in the medical device industry (Quality Assurance preferred) Understanding of cGMP, QSR, ISO 13485 requirements, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP). Ability to understand and follow Quality Management System Procedures (e.g., SOPs and Test Methods). Ability to understand reading and interpreting technical specifications and mechanical drawings. Knowledge of common medical device inspection techniques and methodologies. Knowledge of inspection and test equipment. Knowledge of inspection and testing activities related to Design Validation and Verification in the medical device industry. Excellent visual acuity to perform visual inspections involving small defects, small parts, and operation of machines using measurement devices. Operate as a team and/or independently while demonstrating flexibility to changing requirements. Experience with computer-based applications (MS Suite) Able to work in the Controlled Environment Room (CER) Strong written and verbal communication skills. Ability to work in a fast-paced environment while managing multiple priorities. May be required to lift objects up to 25 lbs. 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. Compensation
The anticipated base pay range for this position is: $22.67 - $36.24 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 Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys 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 #J-18808-Ljbffr
Johnson & Johnson believes 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. 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 Technician II Shockwave Medical
to join our team located in
Santa Clara, CA . Fueled by innovation at the intersection of biology and technology, were developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team thats 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 Technician II provides support to the Design Quality Engineering (DQE) team in daily activities. This role involves reviewing inspection and test data for adherence to Good Documentation Practices (GDP). The Quality Technician II must also be able to perform inspections and testing using various measurement systems. Essential Job Functions
Review test and inspection data to ensure compliance with Good Documentation Practices (GDP). Audit data collection processes for GDP compliance. Perform basic calculations and data analysis. Perform Document Change Orders for continuous improvement, or update according to GDP requirements: Data collection forms, Procedures, and Test Methods Review test data for accuracy when transferred/transcribed from data collection forms to any statistical or calculation software files for analysis. Review inspection and testing reports in accordance with Current Good Manufacturing Practices (cGMP) and maintain inspection and testing files as per established procedures. Perform inspection and functional testing of medical device components, tools & fixtures, subassemblies, and finished goods using various measurement systems (e.g., Scienscope, laser micrometer, pin gauges, height gauges, optical instrumentation, Instron, calipers, snap/drop gauges, balloon burst tester, etc.) per specifications or test protocols, and generate Non-Conformance Reports (NCRs) as necessary. Conduct functional testing of components, assemblies, and finished products according to required specifications or test protocols. Support company goals, objectives, policies, procedures, Quality System Regulations (QSR), and FDA regulations. Interface and communicate effectively with cross-functional project team members. Perform other duties as assigned. Requirements
High school diploma with a minimum of 2 years of experience in the medical device industry (Quality Assurance preferred) Understanding of cGMP, QSR, ISO 13485 requirements, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP). Ability to understand and follow Quality Management System Procedures (e.g., SOPs and Test Methods). Ability to understand reading and interpreting technical specifications and mechanical drawings. Knowledge of common medical device inspection techniques and methodologies. Knowledge of inspection and test equipment. Knowledge of inspection and testing activities related to Design Validation and Verification in the medical device industry. Excellent visual acuity to perform visual inspections involving small defects, small parts, and operation of machines using measurement devices. Operate as a team and/or independently while demonstrating flexibility to changing requirements. Experience with computer-based applications (MS Suite) Able to work in the Controlled Environment Room (CER) Strong written and verbal communication skills. Ability to work in a fast-paced environment while managing multiple priorities. May be required to lift objects up to 25 lbs. 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. Compensation
The anticipated base pay range for this position is: $22.67 - $36.24 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 Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys 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 #J-18808-Ljbffr