Job Description - SENIOR QUALITY ENGINEER (3er Turno) (2406213590W) Purpose: Participate in new product/process teams to develop quality-engineered systems and products, lead and support design verification tests, process validations, quality processes to ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies. Drive quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of the product.
You will be responsible for: Working in Quality Engineering and with other functional groups in support of new product/process development, quality operations, or quality assurance.Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.Leading efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction.Developing and establishing effective quality control and support associated risk management plans.Writing, reviewing and/or approving process and product validation protocols and reports, equipment qualifications, engineering change orders.Using statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).Determining sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products.Ensuring that development activities follow design control requirements, product is tested per applicable standards, European Essential Requirements are met per the MDR, and product is properly transferred to manufacturing.Providing all planning necessary to ensure effective product acceptance, including but not limited to part qualifications, specification development, and sampling plans.Supporting vendor audits as technical lead as needed and supporting Supplier Quality as Quality representative as appropriate.Initiating and investigating Corrective and Preventative Actions (CAPA) as appropriate.Assisting in complaint analysis as appropriate.Assisting Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary.Participating in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.Making decisions independently on engineering problems and methods and representing the organization in conferences to resolve important questions and to plan and coordinate work.Consulting with supervisor and providing guidance as needed concerning unusual problems and developments.Supervising and/or providing guidance to Inspectors and Technicians in Quality LCM, Quality Operation or Quality Assurance activities as needed.Planning, developing, coordinating, and directing a medium-sized engineering project or a number of small projects with varying levels of complexity.Carrying out assignments requiring the development of new or improved techniques or procedures.Assessing the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary.Communicating business-related issues or opportunities to the next management level.Ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices.Ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.Performing other duties assigned as needed.Qualifications: Bachelor's degree in a related field, along with a minimum of 4 – 6 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required. Master's degree is preferred.American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.Knowledge of GD&T (Geometric Dimensioning and Tolerancing) is desirable.Ability to develop and implement Quality standards.Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices.Thorough knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.Ability to apply project management skills to ensure fulfillment of new product development requirements.Demonstrated auditing and problem-solving skills.Understanding of Six Sigma and Business Excellence tools and methodologies. Lean manufacturing experience desirable.Ability to train and mentor a diverse array of employees on quality topics.Good understanding of theoretical and practical fundamentals and experimental engineering techniques.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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