Manager Level - Quality Operations Lead (80-100%)

Quality Operations Lead 80-100%

Are you ready to take on a unique and exciting opportunity as a Quality Operations Lead in the Medical Device Sector? Johnson & Johnson is seeking a highly motivated individual to join our team in Nijmegen, Netherlands. This is your chance to be part of a world-class organization that is committed to innovation and delivering flawless quality in everything we do.

As the Quality Operations Lead, you will play a crucial role in ensuring that our operations meet the highest standards of quality and compliance. You will have the opportunity to work with a team of exceptional professionals and contribute to the success of our goals. With your proven expertise and leadership, you will be at the forefront of driving our quality initiatives to new heights.

This position reports to the direction of the Director of Quality and Regulatory Affairs.

The Quality Operations Lead will supervise a team of Quality Engineers supporting manufacturing lines, operator certification program, non-conforming material management, all in accordance with applicable regulations and written specifications and quality standards. The successful candidate will implement and lead the quality operations organization for the Ethicon Nijmegen site by:

• Planning, coordinating, and directing quality programs designed to ensure continuous production of products consistent with established standards
• Serving as the Quality Operations Site Lead and coordinating quality operations
• Driving Quality System efficient execution and reduced risk of non-conforming product

Responsibilities:

Under limited supervision, and in accordance with all applicable laws, regulations, procedures and guidelines, this position:

• Ensures that performance and quality of medical devices (class III) conform to established company and regulatory standards.
• Participates with Operations in developing, coordinating and implementing projects for improvement of processes and/or products.
• Provide feedback to operations on problems related to quality and/or compliance.
• Administers the deployment and utilization of resources for tactical day to day work. This includes working with Operations, Supply Chain and QA to facilitate operations scheduling.
• Reviews and approves non-conformances, CAPA, Audit Observations, Change Controls, Validations and Completion Reports, and other quality system documents or records as required.
• Leads the qualification and validation for all products and processes.
• Supports investigation, evaluation, and implementation of actions to eliminate root causes of non-conformances.
• The individual has the necessary independence, authority, and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality issues, initiate, recommend, provide and verify solutions.
• Ensures effective risk management process is implemented to prevent unanticipated failure.
• Acts as advisor to help meet established schedules or resolve technical or operational problems.
• Formulates and maintains quality operations objectives and coordinates objectives with the rest of the organization common objectives.
• Ensures all products meet and/or exceed company and local government standards.
• Participates in auditing of production areas and systems.
• Reviews reports findings and makes recommendations for corrective action.
• Responsible for Succession Planning, Goals and Objectives, and Salary planning for direct reports and subordinates.
• Actively supports other plant functions in the implementation of company programs and projects.
• Develop, update and enforce quality operations procedures and guidelines
• Enforces, promotes, and observes all safety, environmental, industrial hygiene rules and regulations established by the Company.
• Responsible for communicating business related issues or opportunities to next management level.
• Provides active support to investigation and resolution of Product Issue Escalations.