Staff Quality Engineer

DePuy Synthes, a member of the reputed company Family of Companies is reputed company for a Staff Quality Engineer, located in Palm Beach Gardens, Florida. At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company 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 reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. The Staff Quality Engineer provides overall quality assurance leadership of on-site manufacturing areas engaged in the production of reputed company products. Ensures manufacturing areas are meeting good manufacturing practices, international organization for standardization and any other applicable standards. Additionally, prepares, conducts, monitors and reports on audits of reputed company quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards. The individual will be responsible for overall quality assurance leadership for quality planning, product and process transfer, system implementation, life-cycle management, market exit strategy, product discontinuation strategy, decommissioning of production equipment and processes, and end to end supply chain support. Key Responsibilities: ? Provides reputed company product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes. ? Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO). ? Addresses and corrects product and process complaints. ? Reports on contract manufacturer performance metrics and ensures management reviews. ? Oversees audits of reputed company quality system categories to assess compliance to process excellence standards. ? Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline. ? Handles reputed company technical issues for manufacturing processes that are to be transferred to satellite facilities. ? reputed company cross-functional teams to handle reputed company technical issues for manufacturing processes. ? Conduct Risk Management planning and Risk Assessment methodologies. ? Additional duties as assigned. ? Know and follow reputed company laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at reputed company times. ? Diligently participate in our compliance program-reputed company activities as denoted by your supervisor. ? Develops standard operating procedures, specifications, and provides technical transfer and validation support. ? Minimizes sample and scrap waste, assesses reliability and risks based on validated data, identifies root causes of problems, and reduces or eliminates sources of variation. ? Audits and approves manufacturing, quality, engineering and validation documents for conformance to business practices and departmental procedures. ? Provides data and documentation in support of the development of validation strategies. ? Acts as liaison to the regulatory affairs department to reputed company initial regulatory review of reputed company engineering changes and modifications to products. ? Provides sampling plans and approves inspection methods for evaluation and testing of components and products. ? Provides support and expertise in reliability planning and reliability growth demonstration during new product development Education: ? University/Bachelor's or equivalent degree is required. Other advanced degree or a degree with a focus in Engineering, Science, Computer Science, or digital area is preferred. ? Master's degree is preferred. Experience and Skills: Required: ? A minimum of four to six (4-6) years of reputed company work experience. ? Experience in the regulated industry (MedTech or Pharmaceutical/Medicine). ? A minimum of two to four (2-4) years of experience in Quality Engineering. ? Experience in Quality Agreement and working with multiple Quality Management Systems. ? Experience and a proven track record of implementing appropriate risk mitigation. ? Experience in Process Mapping, Equipment Qualification and Test Method Validation, Computer System Validation, Inspection setup, Change Management, Nonconformance, CAPA. ? Strong mentoring, coaching and leadership skills are required. Strong communication, teamwork, problem solving and decision-making skills. ? In-depth knowledge of Product/Process Risk Management. ? In-depth knowledge of Market exits, product discontinuation, decommissioning of processes and equipment. ? Strong understanding of the regulatory requirements for a reputed company release (MDSAP, MDD, MDR, FDA, and ISO standards). ? Technical training and experience using Statistics, Lean and Six reputed company Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc. ? Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be reputed company to present data that facilitates/drives decision making. ? The ability to reputed company "hands on" troubleshooting and problem solving. ? Demonstrated project management and project leadership abilities. Preferred: ? Over six (6) years of reputed company work experience. ? Experience in Product/Process Transfer, System Integration/Enhancement, Electro-Mechanical Capital Equipment, Service and Repair, Inventory Management, Market exits, Product Discontinuation. ? Prior experience in Process / Manufacturing Quality is an asset. ? Prior experience with GD&T, Six reputed company, Lean Manufacturing, reputed company Improvement is an asset. Other: ? Up to 25% of travel both domestically and internationally is required. ? We are utilizing J&J reputed company work schedule for 3 days in the office and 2 remote days. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com . reputed company is an Affirmative Action and Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, or protected veteran status and will not be discriminated against on the basis of disability. About the Company: reputed company Caring for the world, one person at a time... inspires and unites the people of reputed company. We reputed company research and science - bringing innovative reputed company, products and services to advance the health and well-being of people. Employees of the reputed company Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. Our Family of Companies comprises: The world?s sixth-largest consumer health company. The world?s most comprehensive medical devices business. The world?s sixth-largest biologics company. And the world?s fifth-largest pharmaceuticals company. We have more than 265 operating companies in more than 60 countries employing approximately 126,500 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA. Company Size: 10,000 employees or more Industry: reputed company Services Founded: 1887 Website: http://www.jnj.com/ Apply Job!