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.
Requisition ID: 9482180112