Johnson & Johnson Careers
Senior Quality Engineer
Requisition ID: 0825181221
DePuy Synthes Companies of Johnson & Johnson is seeking a Senior Quality Engineer be located in Raynham, MA.
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 Senior Quality Engineer will utilize Quality Engineering (QE) tools and practices for the effective and efficient maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize quality engineering principles, leadership 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 New Product Introduction and Special Projects QE group with a focus on foundry metal casting operations and will oversee other engineers in this role.
- 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.
- Lead a team of 3-5 Quality Engineers supporting projects in the Raynham Foundry operation
- 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.
- 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 and projects as part of design transfer/validations.
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- 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.
- 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 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.
- 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
- Ensures effective quality strategies are created for the validation of test methods, process and design.
- A minimum of a Bachelors Degree in Engineering or related technical field is required.
- A minimum 5 years of related experience is required.
- Experience with IQ, OQ, PQ, TMV (Test Method Validation) or Software Validation is required.
- Manufacturing/Operations experience is required.
- Experience working in both an FDA and European regulatory environment is preferred.
- Experience with metal casting processes is preferred.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is preferred
- Experience with a proven track record of implementing appropriate risk mitigation is highly preferred.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred.
- 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.
- Troubleshooting and problem solving is required.
- The ability to think on the feet and providing sound judgment is highly desired.
- 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 preferred.
- Demonstrated project management and project leadership abilities are required.
- This position will be based in Raynham, MA and may require up to 10% travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Depuy Orthopaedics. Inc. (6029)