DePuy Synthes Companies of Johnson & Johnson is seeking aSenior Manager, Quality Operations in Warsaw, Indiana.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic 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 Manager, Quality Operations will utilize Quality Engineering / Operations tools and methods for the effective and efficient development, transfer, and maintenance of products / processes throughout the product lifecycle.
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.
This individual will ensure effective risk management to prevent unanticipated failure modes and improve capability of processes.
This individual will support processes in Base Business and supervise, lead and mentor other engineers and technicians.
The Senior Manager, Quality Operations will lead or support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
He / she will review / analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and / or other improvement tools and programs.
This individual will conduct benchmarking with external companies or internal sites to develop more effective methods for improving quality.
The Senior Manager, Quality Operations will establish metrics that are leading and lagging indicators of quality.
He / she will support the development of quality engineering, quality compliance, and quality leadership talents with the right skills sets for new product introductions, and product life cycle management
The Senior Manager, Quality Operations will review / analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc..
He / she will champion 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.
He / she will conduct periodic line audits to assess adequacy of production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
The Senior Manager, Quality Operations will partner 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.
He / she will support the development of quality strategies related to the transfer of products, materials and components within J&J or externally.
This individual will support new product introduction as part of design transfer.
The Senior Manager, Quality Operations will provide supervision, mentoring, coaching, performance review, developmental plans, and succession planning for the Quality Operations team.
The Senior Manager, Quality Operations will lead the team responsible for conducting investigation, bounding, documentation, review and approval of non-
conformances, CAPAs and customer complaints. He / she will have accountability and ownership for material identification, material segregation, and classification of defect types.
He / she will analyze / review effectiveness of preventive and corrective actions while reviewing root cause investigations according to an established process.
This individual will have accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.
He / she will approve IQ, OQ, PQ, TMV or Software Validation. Ensure timely investigations and closures for Non-Conformances for direct staff.
The Senior Manager, Quality Operations will partner 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. He / she will conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan.
This individual will develop measurement systems / capabilities, destructive tests, non-destructive tests for manufacturing processes.
The Senior Manager, Quality Operations will develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
He / she will develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process / product risk.
He / she will have accountability and ownership for sampling plans of all types. This individual will assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
The Senior Manager, Quality Operations Engineering will 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. He / she will assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
He / she will have ownership and accountability of risk assessment process including conducting, documenting, reviewing or maintaining current risk and hazard analysis documentation such as Process FMEAs given product / process changes.
Estimates budget for the Quality Operations Value streams and maintain operating costs within constraints of those budgets.
Cooperates with other management personnel in formulating and establishing local and worldwide company policies, and procedures, and goals.
He / she will conduct strategic planning with site leaders and Product Engineering Team. Partnership with other functions to establish business priorities and resource allocation.
Carries out management responsibilities in accordance with the organization's policies and applicable laws.
A minimum of a Bachelor’s Degree is required. A Bachelor’s Degree in Engineering or related technical field is preferred.
A minimum of 8 years’ experience in a GMP and / or ISO regulated industry is required.
A minimum of 4 years’ experience of people management is required.
Experience working in both an FDA and European regulatory environment is preferred.
Experience working in manufacturing / operations environment is preferred.
Product / process Risk Management experience is required.
Advanced Technical Training and experience using Statistics, Lean and Six Sigma Methodologies is preferred, including Measurement System Analysis, SPC, DOEs, Reliability, etc.
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 is required.
The ability to perform "hands on" troubleshooting and problem solving is required.
Technical understanding of manufacturing equipment and processes is preferred.
Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
This position is located in Warsaw, Indiana and require up to 10% travel.