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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

We are searching for the best talent for a Quality Engineer to be in San Lorenzo, Puerto Rico.

The Quality Engineer reports to Quality Operations Lead, Quality Operations Leader or designee and with the objective of maintaining high quality standards for the product manufacturing process and the compliance with regulatory requirements, provides leadership, technical support and direction to Plant Operations and Quality Assurance during the design, development, enhancement, revision and implementation of the quality systems for the efficient manufacturing of products and processes. Provide support and expertise on problem solving, process improvements and in the usage of quality tools. Ensure compliance with company policies and procedures such as Design Control, Process Validation, Test Method Validation, and Sampling Plan Development and Review. Generates quality indicators and supports nonconformance investigation and corrective action implementation at the business unit level and/or Plant level.

You will be responsible for:

• Supports Internal Compliance Function as required (QSR/ISO training, internal and external audits, trends analysis, etc.).
• Ensures compliance of areas of responsibility with the department, company, OSHA, ISO and QSR concerning safety, good housekeeping practices and manufacturing practices.
• Supports Operations in the generation of quality indicators, evaluation and implementation of action plans to eliminate root causes of non-conformances and in the development and execution of strategic and tactical plans to run base business.
• Lead and/or support Plant Initiatives and/or special projects.
• Supports/initiates investigations of non-conformances (such as but not limited to NCR, CAPA, Audit Observations), and initiates and maintains interplant communications of quality issues.
• Applies Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Root Cause Analysis, Statistical Analysis and Design of Experiments (DOE) to the improvement of products or processes and in solving process/product-related problems. Promotes and applies Process Excellence Methodology to improve products/processes/systems. Supports validations as required.
• Performs other tasks as assigned by the Quality Operations Lead, Quality Operations Leader or and/or Site Quality Lead.
• Develop, write and approve as required policies, procedures, test methods, specifications.
• Support the Plant Sterilization processes.
• Provide expertise in the design, development, and implementation of suitable quality systems for new or existing products & processes. Facilitate the design transfer process between corporate and plant environments.
• Conduct internal audits and external (supplier, contractor, contract laboratory) audits, in QSR’s and ISO9000, as well as assessments of technical, engineering, operations, & quality related areas.
• Approve and support the control and disposition of non-conformance material as per applicable procedures.
• Perform product impact assessments and the determination of non-conformances scope (i.e. bounding).
• Attend and support Operation meetings.
• Support manufacturing in the day-to-day troubleshooting situations and actively participates on Integrated Production Team’s (IPT).
• Acts as a designated Quality Operations Lead or Quality Operations Leader when needed.
• 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.

Qualifications

• A minimum of a Bachelor's degree in Engineering, an Applied Science or a related technical and quality field is required.
• A minimum of 2 years of work experience with a minimum of one (1) years of related experience in a regulated industry is required; Medical Device experience is preferred.
• Intermediate or higher computer skills and use of software application(s) is required.
• Fully bilingual (Spanish & English) is required.
• Knowledge of QSR and ISO Standard is preferred.
• This position may require up to a 10% of domestic and/or international travel.
• This position will be based in San Lorenzo, PR and will also provide support to Manatí, PR site as business requires.
• Availability to work various schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays.

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.