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ETHICON is recruiting for a Quality Engineer, located in San Lorenzo, PR.
Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.
This position will report to Sr. Quality Operations Manager, Quality Manager 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. Provides support and expertise on problem solving, process improvements and in the usage of quality tools. Ensures 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 non-conformance investigation.
Supports Internal Compliance Function as the need arises (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 the need arises.
Performs other tasks as assigned by the Quality Manager and/or QA Plant Director.
Develop, write and approve as required policies, procedures, test methods, specifications.
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.
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).
Support manufacturing in the day-to-day troubleshooting situations and actively participates on Integrated Production Team’s (IPT).
Bachelor’s degree in engineering field is required.
Experience and Skills:
Fully bilingual (Spanish & English)
Intermediate or higher computer skills and use of software application (s).
Knowledge of QSR and ISO Standards.
A minimum of one (1) years of related experience in a regulated industry is required
Medical Device experience is preferred.
EIT, PE License preferred.
10 % Domestic Travel may be required
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.
United States-Puerto Rico-San Lorenzo-
Ethicon Endo Surgery, LLC (7597)