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Job Description:

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:
• Dedicated to developing, manufacture, and market quality products.
• Reviews and analyses quality trends with the manufacturing team. Considering the quality trends provides direction in terms of setting work priorities for process enhancement.
• Provides guidance to manufacturing supervisors to ensure that effective in-depth investigations are performed.
• Provides leadership and guidance to cross functional, 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 and the Manufacturing Manager, 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 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.
• 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, cross functional 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 enhancement 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:

• Bachelor’s degree is required. Bachelors Degree in Engineering or Science Degree preferred. Master’s Degree preferred.
• Requires minimum of six 6 years work experience.
• Four (4) years of experience in the QSR/ISO required - regulated medical device operation preferred.
• Experience in a quality role within the manufacturing industry preferred.
• Willing to Travel 50% to Manati site is required.