Senior Quality Engineer

Are you an experienced Quality Engineer looking for a new and exciting challenge? Look no further! Johnson & Johnson is seeking a Senior Quality Engineer to join our exceptional team in Raynham, MA! 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.com/ . 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. At Johnson & Johnson, we pride ourselves on our world-class products and our commitment to making a difference in the lives of people around the globe. As a Senior Quality Engineer, you will play a vital role in ensuring the quality of our products, maintaining our reputation as a leader in the industry. This is a unique opportunity to be part of a company that is dedicated to delivering innovative and life-changing healthcare solutions. Key Responsibilities: • Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements), including providing support during internal and external audits. • Conducts investigation, bounding, records documentation, review and approval of non-conformances, CAPAs and customer complaints. Raises quality issues as appropriate. • Accountability for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing. • Analyzes/reviews effectiveness of preventive and corrective actions. Review root cause investigation according to an established process. • Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality. • Represents as a Subject Matter Expert (SME). • Supports or leads in developing validation strategies. • Approves IQ, OQ, PQ, TMV or Software Validation. • Partners with J&J Global Supply Chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management, and the investigation/correction of process failures when needed. • Collects data and executes/conducts various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. • Documents, justifies, reviews or analyzes whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs