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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 Principal Quality Technician Design Assurance – 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

The Principal Quality Technician provides support to the Design Quality Engineering (DQE) team in day-to-day activities. The Principal Quality Technician will need to be an expert in reviewing inspection/test data for Good Documentation Practices and in educating less experienced technicians the importance of GDP. The Principal Quality Technician should be proficient in performing inspections/testing using various measurement systems and in training/ teaching less experienced technicians in inspection/testing.

Essential Job Functions:

• Coach/mentor and provide guidance for other Quality technicians related to Good Documentation Practices, Inspection techniques, and Testing.

• Review test/ inspection data and ensure data adheres to Good Documentation Practices (GDP)

• Audit data collection processes for GDP compliance.

• Perform calculations and data analysis.

• Perform Document Change Orders for continuous improvement, or update according to GDP requirements: Data collection forms, Procedures, and Test Methods

• Effectively work with cross-functional Engineers in developing inspection plan and test methods

• Perform inspection/testing of medical devices components, subassemblies and finished goods using various measurement systems (e.g., Scienscope, laser micrometer, pin gauges, Instron, calipers, snap/drop gages, balloon burst tester, etc.) and generate NCRs as necessary

• Perform functional testing of components, assemblies, and or finished products following the required specifications or per test protocols

• Generate detailed and accurate inspection and testing reports according with Current Good Manufacturing Practices (cGMP) and maintain inspection and testing files as per procedures

• Use measuring tools, such as pin gages, height gages, calipers, optical instrumentation, etc., to inspect materials (components, tools & fixtures, subassemblies, consumable) and document inspection results as required.

• Support company goals and objectives, policies, and procedures, QSR, and FDA regulations

• Interface and communicate effectively with cross-functional members of project teams

• Train new quality technicians to the procedures and the use of specific tools/equipment

• Other duties as assigned.

Requirements

• High School Diploma with a minimum of 10 years’ experience in the medical device industry (Quality Assurance preferred)

• Excellent understanding of cGMP, QSR and ISO13485 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., SOP and Test Methods)

• Working experience doing data review per Good Documentation Practices (GDP)

• Proficient in reading and interpreting technical specifications and mechanical drawings

• Experience with data analysis and ability to perform calculations

• Extensive knowledge of a wide variety of inspection, test equipment, and test methodologies

• Highly proficient performing inspections and testing activities pertaining to Design Validation & Verification in the medical device industry

• Excellent visual acuity to perform visual inspections involving small defects, small parts, and/or operation of machines using measurement devices

• Ability to communicate effectively with all cross-functional team members

• Operate as a team and/or independently while demonstrating flexibility to changing requirements

• Proficient with MS Office

• May be required to work in a Controlled Environment Room (CER) as needed.

• Excellent 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 25lbs

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Pay Transparency:

• The anticipated salary range for this position is $66,700 - $107,123

• 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 :

$66,700 - $107,123

Additional Description for Pay Transparency: