Senior Quality Systems Engineer

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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, 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.

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