Senior Quality Systems Engineer

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 Systems

Job Category:
Professional

All Job Posting Locations:
Palm Beach Gardens, Florida, United States of America

Job Description:

Employer:          Medical Device Business Services, Inc.

Job Title:            Senior Quality Systems Engineer

Job Code:           A011.5112

Job Location:     Palm Beach Gardens, FL

Job Type:            Full-Time

Job Duties: Perform quality systems duties, including maintenance of corrective action and preventative action (CAPA) and supplier systems.

Provide leadership and project management to special quality projects.

Ensure compliance with the CAPA system and support the Nonconformance (NC) system, including trending, analysis, and reporting of quality metrics.

Facilitate Quality Progress Report (QPR) and Quality System Management Review (QSMR) meetings.

Serve as site trainer for CAPA and NC systems.

Make proposals and assist in the development of CAPA plans and monitor implementation.

Follow up on closure of corrective and preventive actions.

Develop and conduct Effectiveness Monitoring actions.

Conduct investigations, collect data, analyze trends, and prepare reports for assigned quality processes.

Participate in the site’s NC and CAPA program including weekly meetings and status reports (monthly & quarterly reports, data analysis, and trending for management).

Assess current quality systems and recommend improvements to enhance quality and reduce cycle time.

Prepare for and facilitate audits and inspections.

Monitor trends, identify issues, and recommend and implement appropriate actions.

Assist in the development, implementation, and review of standard operating procedures.

Maintain current knowledge of the FDA 21 CFR Part 820, ISO13485:2016, EU MD Directive/Regulations, Japan JPAL, Canada CMDCAS, Brazil ANVISA, Australia TGA, and other applicable regulatory standards considering the countries/regions products are marketed.

Requirements: Employer will accept a Bachelor's degree in Industrial Engineering or related field and 4 years of experience in the job offered or in a Senior Quality Systems Engineer-related occupation.

This job posting is anticipated to close on 6/16/2025.

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...