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 DESCRIPTION:
Johnson & Johnson is hiring for a Sr. Quality Systems Specialist - Shockwave Medical 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
In compliance with FDA, European MDD/MDR & ISO regulations, the Quality Systems Specialist will perform work under general supervision. The general scope of this position is to assist in maintaining quality compliance, managing new geographies Quality Compliance Assessments, managing actions for the audit findings and CAPAs, assisting with External Standards management process, supporting audit activities and compiling quality metrics. This position requires frequent use and general knowledge of industry practices, techniques, and standards.
Essential Job Functions
- Assist in managing audit findings and CAPA actions
- Assist in managing overall compliance of the CAPA and audit systems
- Work cross-functionally with other teams to track and manage Audit findings and CAPA activities from initiation through closure
- Identify and implement CAPA and audit system continuous improvement activities
- Assist with audit preparation activities, conduct and follow up of internal and external audits
- Participate in quality system activities and support internal and external audits as requested
- Coordinate audit related activities (prepare documents, track audit requests, take notes, schedule conference room, setup communication channels, etc.)
- Communicate with Subject Matter Experts regarding the audit requests
- Assist with External records management process
- Assist in managing compliance to the current revisions of the standards
- Coordinate standard related activities (track current revisions of the standards, follow up with standards owners on the status of implementation activities, maintenance of Standards tracker, etc.)
- Gather information and update as needed to ensure compliance with Shockwave Medical procedures.
- Assist with New Geographies Quality Compliance Assessment
- Work with cross functional teams to identify new geographies regulatory and compliance requirements, conduct gap assessments of the QMS to new requirements, determine implementation plans for compliance to the new requirements and follow through on actions till full implementation.
- Assist with quality metrics for trending purposes
- Collect and log data as requested
- Assist in preparation of presentations as needed for data analysis purposes
- Perform QA related data entry and generate reports as required
- Work cross functionally with other teams to collect information, follow up on tasks, etc.
- Support company goals and objectives, policies, and procedures, QSR, and FDA regulations.
- Other duties as assigned.
QUALIFICATIONS
- Bachelor’s degree and 5+ years of related experience performing Quality System related activities in the medical device industry.
- Working knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems.
- Proficiency in data compilation, analysis, presentation, and document writing skills.
- Excellent written and verbal communication skills.
- Excellent organizational skills.
- Experience with computer-based applications (MS Word, MS Excel, QAD).
- 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 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.
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