Johnson Johnson is currently seeking a Quality Team Leader to join our Quality Team located in San Lorenzo, Puerto Rico 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.nj.om/.For more than 130 years, diversity, equity inclusion (DEI)has been a part of our cultural fabric at Johnson Johnson and woven into how we do business every day.Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson Johnson, we all belong.Purpose: Reports to Quality Operations Lead, Quality Operations Leader, Quality Laboratory 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.Generates quality indicators and supports nonconformance investigation and corrective action implementation at the business unit level and/or Site level.You will be responsible for: Under the direction of Quality Operations Lead, Quality Operations Leader, Quality Laboratory Leader or designee and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson Johnson, procedures and guidelines, this position.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.Responsible for the evaluation and disposition of WIP and questionable raw materials by inspecting and testing as needed.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.Lead and/or support Plant Initiatives and/or special projects.Supports/initiates investigations of non-conformances (such as but not limited to Nonconformance Reports (i.NR), CAPA, Audit Observations), and initiates and maintains interplant communications of quality issues.Participates in the interview and selection of qualified employees for authorized job openings.Responsible for the coordination,maintenance and implementation of the Device Master Record.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.Monitor the performance of the CME (Controlled Manufacturing Environment), including but not limited to Product Bioburden monitoring.Schedules, assigns, review, and supervise the work of direct personnel.Performs other tasks as assigned by the Quality Operations Lead, Quality Operations Leader, Quality Laboratory Leader or designee for Inspection and Testing or Quality Site Lead.Directly supervises QA Technicians and other Quality Assurance Non-Exempts Associates such as Quality Technicians, RMQA, Laboratory, and/or Finished Goods as required and trains, develops and evaluates direct reports.Develop, write and approve, procedures, test methods and/or specifications as required.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 ISO, 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.. bounding).Attend and support Operation meetings.Acts as a designated Quality Operations Lead, Quality Operations Leader, or Quality Laboratory Leader when needed.Comply with all environmental, safety and occupational health policies (i.., ISO OSHAS ).This position will directly supervise and manage the priorities of Quality Technicians, Raw Material QA Technicians, Finished Goods QA Technicians and/or Finished Goods Release Coordinators.This position reports to Quality Operations Lead, Quality Operations Leader, Quality Laboratory Leader or designee.Works with other departments such as human resources, Production Planning Control, Operations, Business Excellence and/or Engineering.Participate in Management Review.Host Business Meeting with other functions.Qualifications Bachelor's degree in Sciences is required; concentration in Engineering is preferred.A minimum of 4 to 6 years of professional work experience; 4 years in the regulated manufacturing industry is required.At least one (1) year working in a similar position (Supervisory role) is highly preferred Intermediate computer skills and use of software application(s).Fully Bilingual (Spanish English) The primary location is San Lorenzo, Puerto Rico.10 % of expected travel for domestic, international or both.
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.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.areers.nj.om.
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