Job Scope:

　　Responsible for supporting operators in safely executing production plans provided from planning. Interfaces with Organizational Development (OD) to ensure teams have training and development plans to support operation of equipment and ensure processes are in control. Works with operators to ensure production complies to regulatory and cGMP requirements.

　　Job Summary:

　　Provides leadership of direct reports with emphasis on maintaining quality, improving cost effectiveness, and process improvements that leads to quality, customer satisfaction and service level improvements.Supervises and coordinates the activities of assigned business unit(s) while maintaining flexibility to work within any business unit. Under general direction and guidance, leads all shift activities and manages business unit documentation related to operations. Manages defined metrics in Human Capital, Safety, Quality, Cost, Productivity, Delivery and Service Level.

　　Essential Functions & Accountabilities:

　　Supervises employees and is responsible for overall staffing, planning, training, and employee relations to achieve departmental objectives. As required, will partner with Human Resources to hire, terminate, evaluate, and discipline employees in accordance with current personnel policies. Identifies and addresses developmental needs for individuals and provides training and coaching as appropriate. Coordinate daily priorities in departments. Approve and manage overtime of employees when required. Manages and measures against departmental KPIs and recommends potential solutions to improve processes, equipment performance, quality of product, service level, safety and customer satisfaction. Establishes and drives continuous improvement efforts to maximize efficiencies in the organization. Maintains quality results by utilizing Statistical Process Control (SPC), analyzing the results, taking corrective actions while maintaining Good Manufacturing Practices (GMP) compliance. Assists in and/or initiates data collection activities designed to identify and report on trends relating to efficiency and cost effectiveness. Analyzes data, reports on data and advises as to required operational changes. Partners with other departments and management as required for expediting critical orders, tracking and seeking resolution for any issues. Communicates with all levels of management advising them of day-to-day priorities, etc. Takes appropriate/immediate action to resolve any concerns or issues. Partners with Engineering, Maintenance, Quality and other relevant groups in troubleshooting and resolving process/machine problems. Prepares and communicates daily reports related to production efficiency, waste, downtime, quality, overtime, process problems and related information to employees. Attends and participates in meetings with manufacturing and other department personnel. Conducts departmental meetings as necessary to ensure robust employee communication. Leads equipment/shift changeover process and communication to ensure maximum efficiencies and meet or exceed established standards. Responsible for ensuring that all equipment used in the area is calibrated, functioning properly and that all operators are properly trained in equipment use. Responsible for the documentation, maintenance and monitoring of employee training via departmental Standard Operating Procedures (SOPs). Regularly works in the Electronic Document Control System (EDCS) for handling Non-Conformance Reports (NCRs) along with the ERP system for research of orders. Ensures departmental adherence to Good Manufacturing Practices/Food and Drug Administration requirements, ISO requirements, and safety standards. Monitor business unit Engineering Change Orders (ECOS), Non-Conformance Reports (NCRS), and Documentation Change Orders (DCOS). May monitor and track production supplies and partner with Purchasing/Maintenance to ensure adequate supplies/spare parts on hand. Performs other duties as assigned.

　　Qualifications

　　Experience:

　　Minimum two years directly supervising employees in manufacturing, medical device and/or laboratory settings; internal candidates with at least one year of Operations Coordinator experience will be considered in lieu of supervisory experience. Minimum 5 years of overall manufacturing operations experience preferred. Experience in a regulated manufacturing environment is preferred. Education:

　　Associate's degree required; or an equivalent combination of education and experience required. Bachelors degree preferred. Lean Six Sigma Certification a plus. Knowledge, Skills and Abilities:

　　Microsoft Office Suite required. ERP experience required. Safety knowledge Demonstrated leadership skills Demonstrated process improvement skills Strong communication and problem solving skills Organizational skills Self-motivated and proactive, team-oriented Must be able to lead and facilitate a well-trained workforce. Utilize the concept of continuous improvement, change management and employee teams. Work Environment:

　　Normal production and office environment. Sedentary to light physical effort necessary to perform the job, with frequent exposure to floor equipment and production area involvement.

　　For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $70, 000.00 and $81, 710.00 plus a 5% shift differential. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

　　Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran

　　#LI-AM2

　　Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity

　　Minimum Salary: 0.00Maximum Salary: 0.00Salary Unit: Yearly