Description

Mentor Medical Systems BV is known worldwide as a world-class manufacturer and supplier of medical products. We offer a position in a fast growing, diverse and international organization as we are part of the big American pharmacist Johnson & Johnson since 2009. The company's headquarters are located in Santa Barbara, California (USA). We, as Mentor Leiden, develop and produce high-quality breast implants that are used in plastic surgery.

The Senior Manufacturing Supervisor supervises manufacturing operations and works to meet production goals. Establishes personnel schedules and product lines based on business needs. Provides input to production flow and identifies potential manufacturing issues. Tracks production orders and schedules. Compiles and submits data for production and operating reports. Schedules and/or trains staff in the areas of safety and quality when required. Reviews work to ensure compliance with the standards. Recommends changes to standard operational and working practices. Monitors employees and observes to ensure understanding and compliance. Provides input to operational budget. Manages costs to improve business' financial results. Administers equipment maintenance and repair. Maintains records and notifies management of reoccurring issues that may require equipment replacement. Facilitates departmental communications.

Duties & Responsibilities
Under general direction and in accordance with all applicable laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:

• New Product Introduction (NPI)
  • Supports the introduction of New Products/Equipment.
  • Providing User Requirements (URS) to (line) Engineering
  • Identifies documentation affected (SOP’s and Work Instructions);
  • Supports training for manufacturing operators in the correct use of the equipment; and supports the qualification of the equipment
  • Leads a Shift Team as part of the End-to-End production for which he / she is responsible for
  • assigning a supervisor per team;
  • keeping the data relating to the team up to date and determined as part of the annual budget cycle if the team needs adjustment, including supplying this data for the Five Year plan; timely identification of the need for additional Asset(s).
  • Ensures a safe environment and ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
  • Follows the CREDO and stimulates empowerment
  • Responsible for communicating business related issues or opportunities to next management level.
  • Performs other duties assigned as needed
  • Responsible for keeping all documentation that is necessary for the execution of the process up-to-date
     
• Periodic Review
  • Performs Periodic Review on his / her team. evaluation of the available information (i.e. Training, Non conformances, etc);
  • Report including conclusion;
  • Determining required corrections
  • Overseeing activities and tracks metrics in relation to manufacturing steps end to end, processes, sampling and/or design validations.
  • Responsible for the performance metrics of the department. Such as Non-conformances, deviation, Yield and sick leave.
  • Ensures the month targets are met according MPS (manufacturing Production Schedules)
  • Review and report the performance of the individual team leaders to the next management level and hold at a minimum the 5 performance conversations

• Deviations
  Reviews and approves deviations.
  Responsible to provide information in relation to NC’s, CAPA’s, Incidents or comments. Can use the related system(s)
   
• CAPA
  Supports CAPA’s and can be part of an investigation group.

• Troubleshooting
  Supports Operations in his / her area of expertise where it is expected that he / she can solve the most common problems independently.

• Audits and Inspections
  Acts as an SME for processes for which he / she is responsible.

• Environment, Health and Safety
  • Acts as an SME for processes for which he / she is responsible.

• For those who supervise or manage a staff, leaders are responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• For those who are operational standard owners (EHS Management System). Ensure having clear insight on the standard, whereby identifying the actual gaps, having a plan of mitigation in place to manage risks
• Reviewer of good saves / incident reports based on Curve (Event Management System). Ensuring that the good saves / incident reports are assessed within due date, based on assessment creating CAPA actions where applicable, and ensuring a proper feedback loop within dedicated area and/or department
• Ensuring corporate and site specific KPI's on EHS are met.
• Ensuring performing process confirmation as per schedule whereby maintaining EHS checks

• Compliance
  • Completing training on time
  • Not performing a GxP activity independently until all training and qualification requirements have been completed and documented

• Identification of improvements
  Identifies improvement options for the processes and equipment. These are weighted and well-founded advice for implementation.
   
• Leading improvement projects
  Supports improvement processes
   
• Change controls
  Handles Change management of changes which effects employees.
   
• Projects
  Be the representative of the department in multidisciplinary and global projects.

Qualifications

Minimum Educational level: HBO

• Experience
  Minimum 4 years of working experience
   
• Knowledge
  • Verbal and written communication skills in English and Dutch,
  • business/financial acumen,
  • people leadership, talent development
  • Computer skills in relation to usage to automation software such as Excel, Windows, ERP software
  • Strategic thinking: create targets and development plans to meet business needs
• TWI
  • Performs TWI process confirmation checks as required
• Process Knowledge
  • Has detailed knowledge of the manufacturing Process, within his departmental responsibility. end to end.
• Data Analyse
  • Analytical skills, interpretation of facts, observations and signals to avoid roadblocks
  • six sigma and process excellence tools/methodologies,
  • Can collect and analyze the available data sources to arrive at decision making that is data driven.
• cGMP
  • Familiar with the CGMP requirements insofar as these relate to his / her work.
  • Is responsible for being trained at all times in the applicable procedures.
• EHS&S Standards
  • Fulfilled the training to obtain full VCA certification
  • Familiar with the EHS & S requirements insofar as these relate to his / her work.
• Innovative
  • Is able to see continuous improvements in (work) processes and communicate these to line engineer.
  • Is open to change, innovation and knows how to actively and effectively translate this into the shop floor
• Need for priority
  • Sets the right priorities based on the targets set, where necessary in close coordination with those involved.
• Quality driven
  • Is focused on ensuring a thorough and flawless production process to meet the highest standards
• Communication and relationships
  • Builds strong and productive relationships with all different departments and layers within the Leiden site and within the J&J network. Shows respect for and listens to others. Is aware of their own behavior and the effect on others. Is able to effectively present improvement proposals to stakeholders and thereby guide the decision-making process. Acts from the company's interests and knows how to frame initiatives within the objectives of the department and the site. Presentation skills.
• Improvement
  Is open to receiving / giving transparent and constructive feedback, learns from mistakes and takes the initiative to improve his own work and to realize personal development goals.
• Flexibility
  Is open to change, innovation and knows how to actively and effectively translate this into the shop floor.
• Results
  Driven to achieve business objectives with a high degree of pro-activity, organizational sensitivity and independence. Can identify business goals and translate them into a practical solution in the workplace. Keep an eye on the goal.
• Decision making
  Is able to make well-founded decisions within set frameworks
• Solutions
  Investigates the cause of problems and makes good use of the data. Identifies ideas and actions that focus on structural solutions
• Leadership
  Can manage substantive teams within the department.
  Functions as the primary point of contact of the shift
• Diversity & Inclusion: Optimal use of the different talents, knowledge and skills