Johnson & Johnson Careers
Senior Quality Engineer - New Product Introduction
Requisition ID: 6294180709
DePuy Synthes Companies of Johnson & Johnson is seeking a senior quality engineer to based Raynham, MA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Senior Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize quality engineering principles and problem-solving skills to support, improve, and maintain 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 the Quality Operations New Product Introduction group, partnering with Operations and Engineering in the transfer and validation of new processes and technologies at the manufacturing site.
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Conduct benchmarking to develop more effective methods for improving quality
- Supports the development of quality engineering and quality compliance 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) are in compliance 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 new product introduction as part of design transfer.
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
- Analyze/review 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
- 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.
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
- Develop, interpret and implement standard and non-standard sampling plans
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
- Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.
- Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
- 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
- Ensures effective quality strategies are created for the validation of test methods, process and design.
- A minimum of a Bachelor’s Degree in Engineering or related technical field is required.
- A minimum of 5 years of related experience is required.
- Experience working in both an FDA and European regulatory environment is preferred.
- Experience working in manufacturing/operations environment is required.
- Experience with cleaning and packaging operations is preferred.
- In-depth knowledge of Product or Process Risk Management (FDA and ISO standards) is preferred
- Experience implementing appropriate risk mitigation techniques is required.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and can present data that facilitates/drives decision making is preferred.
- The ability to think on the feet and providing sound judgment is highly required
- Good technical understanding of manufacturing equipment and processes is required.
- Understanding of the NPI (New Product Introduction) Process and Process Validation expertise is preferred.
- A thorough understanding of GMP/ISO regulations and validation regulations is required.
- Demonstrated project management and project leadership abilities are required.
- This position will be based in Raynham, MA and will require up to 10% travel
Depuy Orthopaedics. Inc. (6029)