DePuy Synthes, a member of the Johnson & Johnson family of companies, is recruiting for a Quality Engineer located in Warsaw, Indiana.
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 Quality Engineer conducts assignments encompassing
complete projects or portions of major projects. They determine methods and techniques to be
used or adapt standard methods to meet variations. They coordinate phases of work internally and
The Quality Engineer will utilize Quality Engineering tools
and practices for the effective and efficient development, transfer and
maintenance of products/processes throughout the product lifecycle. The
incumbent will also utilize Quality Engineering principles and problem solving
skills to 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
processes in base business.
Responsibilities & Duties:
• 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.
periodic line audits to assess for production controls such as lot
segregation. Review results of area
audits to ensure that corrective and preventive actions are adequate.
New Product/Process Introduction
• 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.
Product Quality, Control & Disposition and Performance Standards
• Supports activities related to the Material Review Board.
• 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
Production/Process Controls including Control Plans
• 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, 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.
• 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 Bachelors Degree required, preferably in Engineering or related technical field.
• This position requires 2-4 years of related experience.
• Experience working in both an FDA and European regulatory environment is preferred.
• This position will require relevant experience working in manufacturing/operations.
• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Technical training and 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 preferred. 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.
• PFMEA experience highly preferred
• Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
• Demonstrated project management and project leadership abilities are preferred.
• This position may require up to 10% travel and will be based in Warsaw, Indiana.