DePuy Synthes Companies of Johnson & Johnson is currently recruiting for a Senior Quality Engineer (1 of 2) to be located in 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 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, more agile and better equipped to meet the needs of 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.
• Utilize Quality Engineering tools and practices for the development, transfer and maintenance of products/processes throughout the product lifecycle.
• 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.
• Supports the development of quality engineering and quality compliance 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.
• Conduct periodic line audits to assess for production controls such as lot segregation.
• 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 as well as review root cause investigations.
• 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.
• 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.Qualifications
• A minimum of a Bachelors’ Degree in Engineering or related technical field is required.
• A minimum of 4 years of related experience is required.
• Experience working in both an FDA and European regulatory environment is preferred.
• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Technical training and/ or experience using Statistics, Lean and Six Sigma Methodologies is preferred 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 able to present data that facilitates/drives decision making.
• The ability to perform "hands on" troubleshooting and problem solving is required.
• Good technical understanding of manufacturing equipment and processes is required.
• Understanding of the NPI 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 may require up to 10% travel and will be based Raynham, MA.Primary Location
Synthes USA Products, LLC (6317)Job Function