Staff Quality Engineer

STAFF QUALITY ENGINEER At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That's why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. Every day, our more than 140,000 employees across the world are blending heart, science, and ingenuity to profoundly change the trajectory of health for humanity. Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has impacted the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough. JOB SUMMARY The Quality Engineer Staff plans or adapts new methods or procedures to control or coordinate all aspects of several projects at the same time, and to solve related technical challenges. The engineer is an emerging authority in a specific technical field, exercising significant freedom in determining technical objectives. The role aims to develop new or improved methods to reduce risks in equipment, materials, processes, and products. The staff engineer mentors lower‑hierarchy personnel and advises upper management on technical matters. The engineer uses quality engineering practices to develop and maintain products and processes throughout the life cycle, leveraging risk management to prevent unforeseen failure modes and improve process capacity. The engineer provides support to business processes and supervisors or direct technicians. DUTIES & RESPONSIBILITIES Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position: Business Improvement – Revising and analysing the effectiveness of PDCA, Six Sigma, Kaizen, Lean techniques and other improvement tools and programs; benchmarking to develop more effective methods to improve quality; establishing quality metrics; supporting the development of quality engineering and compliance for new products; managing engineering change orders (ECOs); categorizing quality costs and bases of cost. Compliance / Regulatory – Reviewing whether existing products and processes comply with regulations such as QSRs, ISO, etc.; supporting internal and external audits; interacting with regulatory agencies (FDA, JJRC, BSI, etc.); responding to audit observations; maintaining required documentation of quality assurance activities or systems; performing periodical audits to evaluate GMPs, production controls, lot segregation and process audits according to JJPS; revising audit results to ensure corrective and preventive actions are adequate. Finances – Controlling and maintaining the central budget of the department and cost. New Products / Process Introduction – Working with NPI and the manufacturing, process engineering and manufacturing engineering departments to develop, conduct and approve product and process validation strategies. Product Quality, Control and Disposition and Performance Standards – Directing and attending revision meetings of NCs as a member of the MRB; conducting or supporting investigations, bounding, documentation, revision and approval of non-conformities (NCs), preventive and corrective actions. The engineer will also act as a mentor for lower hierarchy personnel and provide advice to upper management on technical matters. #J-18808-Ljbffr