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QUALITY PROJECT LEAD, PORTFOLIO OPTIMIZATION
Requisition ID: 9482180112
DePuy Synthes Companies of Johnson & Johnson is seeking a Quality Project Lead, Portfolio Optimization to be located in West Chester, PA or 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.
The Quality Project Lead for Portfolio Optimization, you will be responsible for leading the project management activities related to quality assurance, for portfolio lifecycle management transformation projects across DePuy Synthes.
This project role is a full-time, salaried duration assignment for 3 years.
Responsibilities will include:
- Engagement and project management of all franchise quality project resources (post market surveillance, customer quality, records management, document management, etc.)
- Implementation and continuous improvement of DePuy Synthes process for product discontinuation
- Mentoring and ensuring compliant implementation of quality and cross-function team members for the product discontinuation process
- Documentation of quality activities related to product discontinuation
- Partner with cross-functional project team members, such as commercial, research and development, supply chain, regulatory affairs to ensure all identification of interdependencies and appropriate risk mitigations
- Provide leader to Quality partners across up DePuy Synthes for executing product discontinuation activities
- Manage detailed quality plans for all quality operations discontinuation activities
- Ensure effective and efficient use of Quality Engineering resources across sites / regions for execution of discontinuation efforts
- Provide guidance and recommendations involving the implementation of regulatory requirements (e.g., Quality System Regulation, EU MDD, ISO standards, etc.)
Position duties & responsibilities:
- Lead transactional lean projects associated with Quality Processes
- Identify process improvement opportunities that will results in target efficiency thresholds
- Collaborate and partner with decision makers across multiple functions and sites
- Follows and observes all regulatory requirements (GMP’s, ISO, FDA, internal policies) applicable to area of responsibility.
- Follow J&J Safety Requirement and safe working conditions and practices in the department.
- Additional responsibilities may be delegated as project needs require.
- A minimum of a Bachelors degree is required in an Engineering or Science discipline.
- Minimum of 7 years overall business experience in a highly regulated business environment.
- Experience in highly regulated manufacturing environment is preferred
- Minimum of 1 year of Project Management experience is required, along with demonstrated cross functional business acumen
- Able to deliver oral and written communications around process improvement projects that have transparency and impact.
- Organized, analytical approach to problem solving. Familiar with FDA, GMP and ISO requirements. Strong computer skills – Microsoft Office, Visio. Working knowledge and proven ability in project management.
- Ability to audit business processes to identify non-compliance to requirements and develop/oversee action plans for corrective action.
- Ability to understand and translate customer needs and insights (Explicit and Implied);
- Ability to develop and implement customer Facing Metric Development
- Required to travel up to 10% as project needs may call for.
Johnson&JohnsonFamilyof Companiesareequalopportunityemployers,and all qualifiedapplicantswillreceiveconsideration foremploymentwithoutregardto race, color,religion,sex,sexualorientation,gender identity,geneticinformation, nationalorigin, protectedveteranstatus,disabilitystatus, oranyothercharacteristic protectedby law.
United States-Pennsylvania-West Chester
North America-United States-Massachusetts-Raynham
Depuy Orthopaedics. Inc. (6029)