Ethicon LLC, a member of Johnson Johnson's Family of Companies, is recruiting for a Quality Engineer Team Leader.
This position will be based at the San Lorenzo facility for approximately 3 months following the start date.
Subsequently, the position will be based at the Manatí facility.
Ethicon is expanding its manufacturing operations to Manatí, Puerto Rico.
Resources hired will work in San Lorenzo temporarily until the Manatí Manufacturing Facility is operational.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, supervises day-to-day activities of the Quality Assurance Technicians, Finished Goods Quality Assurance Technicians, Raw Material Quality Technicians and/or Quality Assurance Laboratory Technicians, in accordance with QSR and Ethicon written specifications and quality standards.You will:Support Internal Compliance Function as required (QSR/ISO training, internal and external audits, trends analysis, etc.
).Be responsible for the evaluation and disposition of WIP and questionable raw materials by inspecting and testing as needed.Support 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.Lead and/or support Plant Initiatives and/or special projects.Support/initiates investigations of non-conformances (such as but not limited to Non-conformance Reports (i.NR), CAPA, Audit Observations), and initiates and maintains interplant communications of quality issues.Be responsible for the coordination, maintenance and implementation of the Device Master Record.Apply 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.Promote and apply Process Excellence Methodology to improve products/processes/systems.Support validations as required.Monitor the performance of the CME (Controlled Manufacturing Environment), including but not limited to Product Bioburden monitoring.Schedule, assign, review, and supervise the work of direct personnel.Directly supervise QA Technicians and other Quality Assurance Non-Exempts Associates such as Quality Technicians, RMQA, Laboratory, and/or Finished Goods as required and train, develop and evaluate direct reports.Develop, write, and approve procedures, test methods and/or specifications as required.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.bounding).Qualifications:A minimum of a Bachelor's degree is required.
Bachelors Degree in Engineering, an Applied Science or a related technical and quality field is preferred.A minimum of 4 years of professional work experience is required.Intermediate or higher computer skills and use of software application(s).Fully Bilingual (Spanish English) required.EIT, PE License preferred.Knowledge of QSR and ISO Standards preferred.Availability to various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays.Six Sigma or Lean certifications will be preferred.Availability and flexibility to work in any of the three shifts is required.10% travel required, must be able to travel between Ethicon Locations (Manatí, Guaynabo and San Lorenzo) and other locations as required by the business (domestic and international travel).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.
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