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

In compliance with FDA, European MDD/MDR & other International Regulations, the Principal Quality Systems Specialist will perform work under minimal supervision. General scope of this position is to support CAPA, data analysis and continue improvements, support Quality system processes, internal and external audits, support External Standards management process and monitoring or key process metrics. This position requires frequent use and general knowledge of industry practices, techniques, regulations and standards.

Essential Job Functions

• Assist in developing, administering, and maintaining quality system procedures and activities to ensure that the SWMI processes and products follow applicable quality standards and requirements

• Participate in external and internal inspections/audits, assist in preparing, conducting the audits and following up on the audit findings. Assist in maintaining a constant state of inspection readiness

• Identify and process preventive and corrective actions

• Compile, analyze and report QMS metrics on a routine basis

• Prepare and support Management Review Reports and KPI reporting

• Review, maintain and approve Quality System documents, records and reports including nonconformance and CAPA records, standards change requests, trending reports, and others as assigned

• Lead improvement projects to completion that may be initiated from non-conformances, audits, etc.

• Support implementation of new products and new country’s requirements within the SWMI QMS activities

• Develop and implement Standards and Regulation tracking and information collection tools, maintain Standards logs with current status, and report on progress of implementation

• Assist in mentoring and training others

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

• Identify and drive Quality Management System continuous improvement activities

• Implementation of JnJ Standards, Procedures, Work Instructions

• Other duties as assigned

Requirements

• Bachelor’s degree and 10+ years of quality related experience in the Medical Device industry

• Excellent working knowledge of current USA Food and Drug Administration (FDA), ISO13485, MDR and other global laws, regulations and standards

• Ability to perform Internal Audits

• Strong background in administering and processing CAPAs

• A commitment to quality and a high level of self-motivation

• Problem solving capability, ability to drive implementation of root cause identification and corrective actions

• Excellent verbal and written communications skills

• Strong interpersonal skills and an ability to work as an effective member of a cross-functional team

• Excellent organizational skills and high attention to detail

• Proficiency in data compilation, analysis, presentation, and document writing skills.

• Familiarity with statistical data analysis tools and concepts

• Ability to work independently

• Working knowledge of computer-based applications (MS Word, MS Excel, Oracle, ETQ)

• Strong time management skills and the ability to multi-task in a fast-paced environment

• 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.