The Process Manager primary responsibility is to organize, manage and ensure the good operations of a work center or process (i.e., the assembly of a mini catheter). The process Manager generates manufacturing documentation, implement and validate processing changes, solve issues and ensures continuity of production flow within his work center. The Process manager interact with other functional groups, such as Document control, Quality, Regulatory Affairs, Research & Development, M&E and Maintenance to ensure the proper operations in his work center including the introduction of new processes or products developed by R&D.
Determines lean methods, processes and procedures to be implemented in his work center and provide guidance/directions to his team.
Reporting to the Production Manager to ensure that products are manufactured to a certain quality standard and adheres to other safety/industry-related regulations in each of the work center.

Why does the job exist? Describe the general overall general purpose of this job in one or two sentences and the value it brings to Natec Medical.
The Process Manager is responsible for the daily output of its cleanroom in term of quality and quantity.
The Process Manager is the leader of a work center including the management and leadership of Team Leaders, Trainers and Operators for all the shifts of its cleanroom.
The Process manager responsibilities include implementing lean processes, proposing and supporting continuons improvements, maintaining set level of productivity and product quality, , as well as ensuring cost-efficient processes and conformance to quality and regulatory standards.
Main Accountabilities
Describe the main tasks which the job holder must perform in order to achieve its objective within each Key Result Area.

Responsibilities within the work center:

• Prioiritize and organise all production activities station by station.
• Optimize the use of materials, equipment and employees in producing quality products.
• Perform the first troubleshooting activity on a process.
• Conduct Kaizen actions to improve process output or quality.
• Organize production processes/operators to ensure that productivity/quality targets are achieved.
• Address and coordinate with others department the resolutions of any process deviations.
• Lead daily Gemba meeting and generate weekly production report with the production manager.
• Anticipate bottlenecks, specify WOF priorities, identifies risks, and escalates issues that cannot be internally resolved.
• Provide technical support on all product and processing related issues.
• Drive continuous manufacturing processes improvements using 5S and lean techniques.

• Ensures required documentation for processes are up to date.
• Ensure GMPs are in place and followed.
• Ensure cleanrooms practices are being respected and followed.
• Identify source of scrap and improve yields.
• Developing good working relationships within the department.
• Develop strong and effective working relationships with the Production team, Quality, Regulatory, R&D to ensure efficient and effective processes.
• Manage Team Leaders, Trainers and Operators.
• Have clear and good communication with all deparments.
• Provides Production Manager with regular updates on all activities.
• Coordinate with Production manager man power recruitment and/or replacement.
• Evaluate employees during the dialogue process directly (i.e, team leader) and indirectly (i.e., operators).
• Communicate any relevant company information and updates to personnel.
• Enforce rules and regulations.
• Handle conflict resolution with support of Production manager and Human Resources team
• Ensure workplace is safe and clean through task delegation and educating personnel
• Conduct training assessments and identify skills or knowledge gaps that need to be addressed.
• Work in collaboration with Production manager and Human Resources department to design and develop training program either external or internal training.
• Orienting new hires to their function and ensure that they get the training needed in relevant areas to do their job well.

• Adheres to company policies and standards.
• Update any existing Quality Management System documents such as Work Instructions, Quality Standard Procedures etc.
• Review IQ/OQ/PQ protocols and coordinate process validation built.

Key Performance Indicators:
Indicate the quantifiable measures that are used to evaluate successful performance in the role (e.g. quality, output rate, accuracy, timeliness, defect rate, variance from targets).

• Work center Yield extracted from X3 reports.
• Daily work center output Catheter or Balloon extracted from X3/Cube reports
• Operator productivity and efficiency
• Staff Turnover and Absenteeism