Ethicon LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Compliance Engineer for the facility located in San Lorenzo, PR.
Located in San Lorenzo, Puerto Rico, the Ethicon, LLC manufacturing facility hosts over 1,000 associates dedicated to producing world-class medical devices to safely and effectively meet the needs of patients from all continents. Ethicon LLC, develops and markets products within three divisions: Ethicon Products for precise wound closure and tissue repair, Ethicon Women's Health & Urology for minimally invasive women's health procedures, and Johnson & Johnson Wound Management for homeostasis and advanced wound care. In 2012 Ethicon, LLC in San Lorenzo was recognized as one of America’s Best Plants by Industry Week Magazine and for the past three years, as one of Puerto Rico’s Best Employers (Mejores Patronos de Puerto Rico).
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Compliance Engineer, under the supervision of the Compliance Manager, is responsible for maintaining a robust compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures, and J&J Corporate requirements.
You will:
• Support and execute external audit readiness activities to ensure site readiness at all times. These activities include audit logistics, front room/back room arrangements, identifying/preparing SME’s, etc.
• Support management of external audits: e.g. Notified Body, Health Authority, Ministry of Health, FDA, Regulatory Agency, JJRC or ERC Audits of the site.
• Support mock external audits/inspections as part of External Audit Readiness activities and internal audits according to the established internal audit procedures.
• Ensure timely and adequate responses to external audit/inspection process and internal audit observations, including failure investigations, root cause analysis and correction/corrective/preventive action plans, monitor and drive on-time completion of all action plans, perform follow-up with owners, and perform effectiveness monitoring and closure.
• Ensure external and internal audit metrics are reported and published. Drive compliance and improvement in metric targets.
• Support the effective deployment of J&J Quality System standards at the site. Connect and collaborate with the compliance teams of other sites and regions.
• Drive compliance and improvements in metric targets. Create reports and communicate performance against metrics to key stakeholders.
• Support implementation of new external regulations and standards for the site.
• Where appropriate, participate on required site teams/projects.
• Provide compliance education and training (QSR, ISO, GMPs) to the site in support of overall educational strategies.
Qualifications
• A minimum of Bachelor’s degree in Engineering is required.
• Training in Process Excellence/Six Sigma tools and methodologies and Certification is preferred.
• Current Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) and/or Lead Auditor certification highly preferred. Must be able to become certified within 1 year.
• A minimum of two (2) years of experience in the FDA/ISO/Health Authority regulated industry (pharmaceutical, consumer or medical devices) is required.
• Experience in Quality, Manufacturing or Engineering roles is preferred.
• Auditing experience is preferred. Experience leading or managing an internal audit program is highly preferred.
• Experience in leading and managing projects and milestones is preferred.
• Experience in supervisor position is preferred.
• Knowledge of FDA/ISO/Health Authority Quality System regulations and standards is highly preferred.
• Good written and oral communication skills as well as report writing, presentation and training skills both in English and Spanish.
• Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required. Experience with Microsoft Project and Minitab is preferred.
• The position requires up to ten percent (10%) of travel.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
United States-Puerto Rico-San Lorenzo- Organization
Ethicon Endo Surgery, LLC (7597)
Job Function
Quality (Eng)
Requisition ID
0723191203
