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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:

Supply Chain Engineering

Job Sub** **Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

San Lorenzo, Puerto Rico, United States of America

Job Description:

Ethicon LLC is recruiting for a Process Quality Leader position, located in San Lorenzo.

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

Under the direction of the Business Unit Leader, provides technical leadership towards the identification of the causes for non-conformances and process failures, and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Ethicon’s QSR, GMP, and ISO requirements for the entire Business Unit manufacturing process.

Key Responsibilities:

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

+ Reviews and analyses quality trends with the manufacturing team. Considering the quality trends provides direction in terms of setting work priorities for process improvement.

+ Provides mentorship to manufacturing supervisors to ensure that effective in-depth investigations are performed.

+ Provides leadership and mentorship to multifunctional, multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented. Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same.

+ Leads investigations of the negative trends and in alignment with the Process Engineer, Quality Engineering, manufacturing, and facilities the implementation process.

+ 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 improvement of processes and systems.

+ Provides training and education to the operations team on tools for process evaluation and improvement. (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.

+ Handles, prepares data and present product escalation investigations (PRE’s), near misses and QRB.

+ Leads in-process investigations with a multifunction team to determine root causes and provides recommendations for corrections on preventive actions.

+ Handles preliminary investigations of product complaints, analysis, trends and recommendations or leads corrective/preventive actions.

+ Provides technical supervision to multilevel, multifunctional teams. Provides supervision to technical professionals such as Process Quality Technicians, College Recruits, Coops or Supervisors that are assigned to work on projects related to process improvement initiatives.

+ Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001)

+ Responsible for communicating business related issues or opportunities to next management level.

+ For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

+ Performs other duties assigned as needed.

Qualifications

Education:

+ Bachelor’s degree is required, Bachelors in Engineering or Science preferred.

Experience and Skills:

Required:

+ Requires minimum of six 6 years work experience, with at least four (4) years of experience in the QSR/ISO required - regulated medical device operation preferred.

+ Availability to various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays.

+ Fully bilingual (Spanish & English) required

+ Advanced digital literacy (Microsoft Office) and use of software application(s) are required.

+ Must have thorough knowledge in QSR, GMP, ISO, knowledge in applied statistics and failure mode analysis techniques.

+ Proficient in the preparation of technical reports and presentations.

+ Strong communication and interpersonal skills.

+ Requires good negotiation skills. Entails heavy interaction with technical peers and manufacturing associates, in operations in the mainland.

+ Position requires leadership skills, teamwork, initiative, innovation, assertiveness, attention to detail and effective interpersonal skills.

Preferred

+ Master’s Degree preferred.

+ Experience in a quality role within the manufacturing industry preferred.

Other:

+ Will require sitting for extended periods of time, writing reports on the computer.

+ Some traveling may be required 10%.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .]

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 ([email protected]) or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy