Engineer 1, Source Quality

DePuy Synthes Companies is a member of Johnson & Johnson's Family of Companies and is recruiting for an Engineer 1, Source Quality located in Warsaw, IN. DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com. Key Responsibilities: Under the direction of a Sr. Engineer, the Engineer I, Provides quality engineering leadership in the management of select External Manufactures, Direct Material, and Indirect material suppliers. Responsible for technical leadership in establishing quality expectations at the supplier. Implements, and/or maintains, production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, process performance metrics). Partner with product development teams to support successful launches at suppliers. Conduct supplier visits emphasizing quality improvement and compliance with good manufacturing practices, ISO-13485 and other applicable standards. Provide Quality Engineering support to suppliers including inspection technique support, product non-conformances, verification/validation activities. Contributes to root cause investigations using various problem-solving techniques and tools, and assesses corrective action effectiveness. Applies various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis). Communicate at all levels within Quality and across functions or departments such as R&D, Regulatory, Manufacturing, and Marketing. Qualifications Education: A minimum of a Bachelor's degree in Engineering or related Scientific focus is required. Experience and Skills: Required: Excellent problem solving and decision-making skills Communication/Interpersonal skills and flexibility to enable resolution of technical situations. Preferred: Relevant work, internship, or Co-Op experience Experience or knowledge with manufacturing processes; machining, injection molding, additive manufacturing and/or electronics manufacturing Medical Device and/or Pharmaceutical industry Six Sigma, Lean, or ASQ Certification/training Quality engineering experience Experience with Blueprint reading/literacy including GD&T Familiarity with inspection methods and techniques Knowledge of FDA CFR Part 820 and ISO 13485 Experience with process validation Other: This position may require up to 25% travel. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. 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. 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. Primary Location United States-Indiana-Warsaw-700 Orthopaedic Drive Organization Medical Device Business Services, Inc (6029) Job Function Engineering Requisition ID 2206026244W