Process Quality Engineer

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.jnj.comJob FunctionSupply Chain EngineeringJob Sub FunctionProcess EngineeringJob CategoryScientific/TechnologyAll Job Posting Locations:Norderstedt, Schleswig-Holstein, GermanyJob DescriptionJOB SUMMARY*The Process Quality Engineer provides technical knowledge towards the identification of the causes for non-conformances and process failures, and for the implementation of the immediate, corrective and preventive actions thus compliance with all applicable regulatory requirements and company policies for the entire Business Unit manufacturing process.DUTIES & RESPONSIBILITIES*Under And In Accordance With All Applicable Federal, State And Local Laws/regulations And Corporate Johnson & Johnson, Procedures And Guidelines, This PositionReviews and analyses quality trends with the manufacturing team. Considering the quality trends, recommends actions for process, equipment and system improvement.Provides guidance to manufacturing supervisors to ensure that effective in-depth investigations are performed.Provides guidance within cross functional, multilevel technical teams to assure causes of non-conformance are identified and that sound corrective/ preventive actions are implemented.Review and actively use process and documentation Key Performance Indicators to identify improvement opportunities and drive or support activities to increase performance.Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same.Analysis of data and based on the trends recommends actions for process, equipment and system improvement.Responsible and accountable as leader of project management (e.g. CAPA lead, internal Observations lead) including managing internal and external resourcesApplies the J&J Quality procedures and Six Sigma principlesApplies the standards of the J&J related Change Management principlesEnsures safe working conditions and practices in the department as well as providing support on the plant safety training requirements.Responsible for communicating business related issues or opportunities to next management levelFor 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 applicableResponsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and proceduresPerforms other duties assigned as neededEXPERIENCE AND EDUCATION*At a minimum, Bachelor’s degree (Engineering or equivalent in a Life Science, Engineering, or Physical Science field). Master’s degree preferred.Experience in the QSR/ISO-regulated medical device operation preferredREQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*Distinct communication skillsDistinct analytical thinking capabilities, prudent risk takingSix Sigma and/or Lean education and/or other sound statistical knowledgeThorough knowledge in QSR, GMP, ISO, knowledge in applied statistics and failure mode analysis techniquesProficient in the preparation to technical reports and presentationsGood MS Office knowledgeSound knowledge about technical standards and legal requirementsGerman, fluent speaking and the ability to describe complex technical topics understandableEnglish, fluent speaking and the ability to describe complex technical topics understandableAt Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.Here’s What You Can ExpectApplication review: We’ll carefully review your CV to see how your skills and experience align with the role.Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process!#RPOEMEA