דרושים Operations Coordinator ב-United States

**Given the scope of this role, this position can be based at any West location**

• In coordination with multi-site leadership teams and the Global Lead Manufacturing Operations, Seals; assist in developing an implementation strategy for end-to-end manufacturing within each site
• Partner with site leadership to establish inventory strategies where end-to-end manufacturing is not yet achieved.
• Assist in the implementation of lean strategies as needed across the entire Seals VS
• Assist in the forecasting and execution of the financial targets including collaboration with site leaders and functional leaders in the value stream to identify and mitigate risks to the financial plan/budget
• Partner with commercial team and other leaders within the organization to identify portfolio optimization opportunities
• Assist finance and other cross-functional leaders in accurately capturing product costs
• Assist in the creation and improvement processes of supplier performance – service, quality and cost
• Lead multi-site initiatives on optimization to include harmonizing processes across the Seals network
• Drive digitalization across sites to leverage data and analytics in strategic business decisions
• Assist in ensuring resource allocation planning is performed and that constraints within Manufacturing, Supply Chain, Global Engineering and other functions are resolved as required for overall program success
• Support administration Capital Planning and spend in conjunction with Engineering and Finance
• In close collaboration with Global Lead Manufacturing Operations, Seals; drive agenda and planning processes for key cross functional meetings such as semi-annual operations meetings
• Ensure common best practice approaches are used across sites for safety and quality improvements and initiatives (root cause analysis, Risk Assessment & CAPA)
• Participate in Global Supply Operations Review and drive team alignment

• Bachelor's Degree in a technical discipline to include: Business, Operations, or Engineering preferred

• Minimum of 5-10 years of experience in manufacturing operations
• Bachelor’s degree in engineering, science, or business fields, or years of experience in lieu of
• Strong project management skills
• Operational Excellence experience including lean and Six-Sigma certification

• Knowledge of statistical tools and Minitab
• cGMP knowledge
• Self-motivated, results- and solution-oriented personality
• Very good organizational and project management skills
• Highly analytical and structured way of working
• Ability to successfully collaborate with teams across organizational levels
• Ability to assert technical solutions and standards
• Excellent communication skills and ability to collaborate well with people

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear audible alarms from distances up to 150ft.
• The ability to be able to lift and carry various items up to 50lbs.
• Must be able to travel up to 25 to 50% of the time

In this role, you will be under the direction of the Product Analysis Manager to support activities related to product root-cause failure investigations on electro-mechanical drug delivery devices in a biohazard laboratory. You will additionally drive investigation process lean initiatives, manage communication with internal and external customers, train team members on new devices and assist with coordinating work for the lab technicians.

• Receive, log, and organize all incoming packages, ensuring proper documentation and maintaining order throughout the entire complaint workflow process
• Maintains processes and procedures for receiving handling, storage, and disposition of returned devices according to regulations and company standards.
• Maintains the product analysis lab including supplies, calibration, equipment maintenance, safety adherence, capacity improvements, and access
• Coordinate lean process improvements for device investigations, lab procedures, and daily productivity as needed.
• Communicates with customers regarding product issues and returned devices.
• Creates and maintains a clean, neat, and safe work environment through identifying and resolving potential safety hazards.
• Promotes teamwork and collaboration between departments to optimize processes and resolve problems.
• Monitor upcoming deadlines and ensure all tasks are assigned and completed on time.
• Demonstrates a “Customer Service” approach to all activities and assignments.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Complies with the company’s safety and quality policies at all times, including proper handling of biohazard materials and components.
• Exhibits regular, reliable, punctual and predictable attendance.
• Complies with site and enterprise safety procedures when handling biohazard materials/components and potent drug compounds.

• 0 - 3 years of experience required
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred

• Experience in conducting root cause investigations of field units.
• Experience in laboratory test equipment operation and maintenance such as Instron, CT scanner, oscilloscope, power supply, multi-meter, and microscopes.
• Background in Microsoft excel for the purposes of trending complaint data.
• Background in medical device or pharmaceutical industry.
• Knowledge of lean manufacturing and operational excellence concepts.
• Able to comply with the company’s safety policy at all times.

• Must be able to stand for long periods of time
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to follow directions, multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems