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 Inspection Team Leader is responsible for managing and coordinating the activities of the Quality Inspection team engaged in sorting, testing, and inspecting products and raw materials in order to ensure compliance with quality standards and production schedules while driving process improvement initiatives.
• Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for the quality inspection staff including supervisors, area leads, and associates.
• Utilize Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs to develop and optimize inspection processes that are aligned with the overall Quality and Business vision.
• Makes recommendations to management regarding ways to advance product quality while improving the time to deliver products through the use of improved inspection and final acceptance processes including the evaluation of new technologies.
• Conduct benchmarking with external companies or internal sites to develop more effective methods and technologies for improving quality.
• Implement methods and procedures for inspection, testing, evaluation, and final acceptance activities.
• Develops and communicates department objectives while establishing metrics (leading and lagging)
• Implements changes in production methods, tooling and equipment, space allocations, workforce utilization, production schedules, lines, and other factors required to maintain or improve compliance with quality standards.
• Provides input to requirements and other information in response to requests for proposals, quotes and other business opportunities.
• Owns the budget planning process for the inspection area.
• 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.
• Review results of area audits to ensure that corrective and preventive actions are adequate.
• A minimum of a Bachelor Degree, preferably in Engineering or related technical field is required.
• A minimum of 6 years of experience in a GMP and/or ISO regulated environment is required.
• A minimum of 2 years of specific experience in a management/supervisory/lead role is required.
• Relevant experience working in manufacturing/operations is preferred.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
• Experience with a proven track record of implementing appropriate risk mitigation is preferred.
• Advanced 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 be able to present data that facilitates/drives decision making.
• The ability to perform "hands on" troubleshooting and problem solving is required.
• Excellent technical understanding of manufacturing equipment and processes is preferred.
• Strong mentoring, coaching and leadership skills are required.
• Demonstrated project management and project leadership abilities are required.• This position is based in West Chester, PA and may require up to 10% domestic travel.