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Senior Operations Manager Medical Device

Tampa, Florida, United States
June 14, 2019

Posted By Premium Recruiter


Senior Operations Manager

A leading global provider of innovative and intelligent hardware and software solutions. Our products enable the safe, efficient and effective delivery of outstanding patient care through the utilization of technology and we bring a global network of manufacturing, quality, and engineering to the forefront of the medical industry.


This position is responsible for all activities of each function. Position leads and directs all production departments as well as support functions, which may or may not include EH&S, Building and Equipment Maintenance, Regulatory & Compliance, Quality, Operational Excellence, Manufacturing Engineering, Production Planning & Scheduling, Supply Chain, and Materials Management. This position is responsible for ensuring the operation achieves Safety, Quality, On Time Delivery, Inventory, and Productivity goals as defined in the balanced scorecard. All of which are targeted at achieving internal and external customer satisfaction. Position reports to President.


• BS in Engineering or Equivalent, preferred.

• Working knowledge of MS Office suite and ERP systems.

• 10 yrs. manufacturing experience with increasing leadership responsibility.

• Refined ability to delegate responsibilities and provide leadership and training to key personnel.

• Knowledge of financial reporting and data.

• Advanced written and verbal communication skills (bilingual a plus).

• Six Sigma Green belt or Lean experience preferred.

• Experience managing operations within TS/ISO certified processes. (13485/ FDA 21CFR Preferred).


• EH& S - The manager of operations is responsible for all activities that effect Environmental Health & Safety related to the facility. This includes a proactive approach to Employee Safety and Housekeeping utilizing the 5S system and Behavior based safety. This role is responsible for compliance to state, federal, and local Safety and Environmental regulations. They are expected to manage timely closure of findings and action.

• Supply Chain & Materials Management - The manager of operations is accountable for the management of the company’s inventory assets. This role is responsible to ensure processes and controls are in place for sourcing, planning, supplier quality, materials management, shipping, and logistics. There is a responsibility to ensure that third party operations in supply chain are meeting their targets for delivery, quality, and cost are not impacting the facility's performance items negatively.

• Delivery Performance / Customer Satisfaction - The manager of operations is accountable for their facility's customer satisfaction levels based on the facility's ability to deliver to the customer request and schedule dates. The on-time shipment metrics represent how well the facility is performing to both the customer's expectations as well as our own commitments to them as tracked and measured. This role is responsible for setting the goals, putting in place the organization to achieve those goals, measuring the results and taking timely and effective corrective action as necessary.

• Quality - Manage the production facility's quality system to achieve goals in Soft Errors, Hard Errors, and internal defects. This must be done in a manner that complies with the relevant parts of FDA CFR 21 and ISO 13485. The operations manager must also drive actions for timely closure of Audit Items, CAPA’s, and Complaints.

• Productivity - The manager of operations is responsible for increasing productivity in all areas by correctly applying appropriate improvement techniques, resources, and, when necessary, capital investment. Driving a culture of continuous improvement to influence operational excellence will be a key responsibility. This role must also account for all capital assets in the facility requiring proper care and maintenance of the assets to maintain them in safe working order and that the company’s investments are protected.

• Human Resources / Morale - is responsible for coordinating staffing, training, and salary administration of the facility's work force both hourly and salary