DePuy Synthes Companies of Johnson & Johnson is seeking a Staff Quality Engineer , to be located in Warsaw, Indiana.
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.
The Staff Quality Engineer will utilize Leadership, People Development, Interdependent partnering, and Quality Engineering expertise to ensure efficient and effective Quality/Compliance and continuous improvement in the DePuy Orthopedics manufacturing facility. He/she will also utilize Quality Engineering/Operations principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support Value Stream processes in base business.
Successful results will often be delivered through cross-functional teams that will include Quality engineers/technicians, supervisors, and engineers in their department. Other responsibilities of this role will include, but are not limited to:
Position duties & responsibilities:
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Conduct benchmarking to develop more effective methods for improving quality
- Supports the development of quality engineering, quality compliance, quality leadership talents with the right skill sets for new product introductions, and product life cycle management.
- Review/analyze whether current product and processes (including actions or decisions conducted) comply to standards such as the QSRs, ISO 13485, etc.
- 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.
- Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
- Supports the development of quality strategies related to the transfer of products, materials and components within J&J or externally.
- Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others
- Perform investigations of product non-conformances and/ or processes
- Critical thinking and attention to detail required
- Excellent verbal communication skills and technical writing
- Conduct Risk-based decision making and effective resolution of issues
- Must maintain training requirements for the position
- Perform validation activities as needed
- Assist with and Approve 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.
- Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan
- Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
- Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Develop, interpret and implement standard and non-standard sampling plans
- Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process controls.
- Document, justify, review or analyze 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
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements
- A Bachelor’s degree and a minimum of 6 years’ experience in a GMP and/or ISO regulated industry is required.
- A degree in Engineering is required
- Ability to analyze and present data that facilitates & drives decision making is required
- Experience working in an FDA regulated environment is required.
- Experience working in operations supporting a production environment is required
- Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies (i.e. Measurement System Analysis, SPC, DOEs, Reliability, etc.) is preferred
- Technical understanding of manufacturing equipment and processes is preferred
- Process Validation expertise is preferred
This position is located in Warsaw, Indiana and may require up to 10% travel domestic & international ]
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.
Medical Device Business Services, Inc (6029)