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

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Job Description:

We are searching for the best talent for Process Quality Specialist to be in San Lorenzo, PR!

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https: //www.jnj.com/medtech

Key Responsibilities:

• Leads investigations and rapid response teams (RRT) of the negative trends, quality/product process investigations & product complaints.
• Provides technical leadership towards the identification of the causes for non-conformances & process' failures, and implementation of the immediate, corrective & preventive actions.
• Reviews & analyses quality trends with the manufacturing team & provides guidance for process enhancement setting work priorities, effective in-depth investigation.
• Provides guidance to manufacturing supervisors or support groups to ensure that effective in depth investigations are performed.
• Manage internal audits including the internal audit observations and implementation of corrective actions.
• Analysis of data and based on the trends recommends actions for process, equipment and system improvement.
• Writes procedures, protocols and any other Documentation needed for the enhancement of processes and systems.
• Provides training and education to the manufacturing team on tools for process evaluation and enhancement. (Analytical trouble shooting, FMEA, statistical concept application and QSR/ISO requirements).
• May lead a number of CAPA and should recommend CAPA’s based on negative trends.
• Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).

Qualifications

Education:

• Bachelor’s degree is required

Experience and Skills:

Required:

• A minimum of 2 years of work experience
• Availability to various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays.
• Bilingual (Spanish & English)
• Must have thorough knowledge in QSR, GMP, ISO and failure mode analysis techniques and analytical problem solving.
• Requires good negotiation skills.
• Position requires leadership skills, teamwork, initiative, creativity, assertiveness, attention to detail and effective interpersonal skills.
• May requires working / visiting all three shifts of the operation and working irregular hours.
• Will require sitting for extended periods of time, writing reports on the computer.

Other:

• Position may be based in San Lorenzo o Manatí Facility, subject to hiring work center requirement.
• 10% Travel requirement between Ethicon Locations, Domestic and/or international travel.

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.