Operations Manager

Essential Job Duties and Responsibilities:

• Oversees personnel associated with design, development, manufacturing and warehousing
• Develop the manufacturing plan and establish required headcount to achieve plan and expected service levels.
• Establish and maintain procedures for design, development and manufacturing operations to ensure that products and processes conform to established regulatory quality system regulations and standards (including FDA QSR and ISO13485), customer and company quality standards.
• Direct the design, development, building and testing of new, serviced and reprocessed products for human use per appropriate Bill of Materials and Work Instructions and other guiding documents.
• Coordinate and perform training of customer Approved Service Center personnel both on-site and at customer locations
• Manage the Inventory Management System to ensure accurate bills of material and other activities related to overseeing the use of the MRP system and system maintenance
• Manage production plan including the planning of materials
• Manage design, development and engineering projects ensuring compliance to design control requirements, generate applicable protocols while maintaining regulatory requirements.
• Use MRP system to manage purchase orders for the timely delivery of materials needed for production, service and general part sales
• Review sales data for sales trends for parts and accessories. Plan and purchase parts accordingly
• Direct and monitor employees under their responsibility to ensure compliance with consistent with good safety practices.
• Act as liaison between subordinate levels, and executive/department manager levels to inform personnel of communications, decisions, policies and all matters that affect their performance, attitudes and results.
• Recruit employees, assign, direct, and evaluate their work, and oversee their development. Take corrective action as necessary on a timely basis and in accordance with company policy.
• Perform annual employee performance reviews and merit increase recommendations.
• Identify, recommend and implement changes to improve productivity and reduce cost and scrap, monitor scrap and rework data. Report on production and service metrics based on the data available
• Direct the establishment, implementation and maintenance of design, development and production standards.
• Direct and coordinate various programs essential to manufacturing procedures (e.g., training, safety, housekeeping, cost reduction, worker involvement, security, etc.).
• Supervise material control, including the handling of released components, handling of non-conforming components, and completed products for areas of responsibility.
• Initiate and coordinate major projects, (e.g., design, development, plant layout changes, installation of capital equipment, etc.).
• Review the accuracy of Device History and Service Records and approve for submission to Quality Assurance
• Other duties and special projects as assigned.

Supervisory Responsibilities: Team Leads, Operations Associates, Warehouse Supervisor, Design personnel

Knowledge, Skills and Experience required (unless otherwise noted):

• Minimum of five (5) years supervisory experience in a manufacturing environment controlled under regulatory requirements.
• Bachelor's degree in engineering, chemistry, biology or related technical degree.
• Project management and coordination experience desired.
• Experienced with Strategic Planning and Continuous Improvement practices; including supporting new product introductions into Manufacturing.
• Experienced in Materials/Enterprise Resource Planning (MRP/ERP) systems.
• Experienced in design and development planning and project management.
• Knowledge and understanding of applicable state, federal and international regulations.
• Strong complex problem solving and decision-making skills needed to evaluate alternatives; including research and data analysis.
• Demonstrated ability to interact successfully with all levels of personnel.
• Excellent leadership, interpersonal, and motivational skills; including strong negotiation and conflict resolution skills.
• Demonstrated ability to take initiative, to use good judgment, to maintain confidentiality, to meet deadlines, and to work in a team environment essential.
• Demonstrated ability to be flexible and possess strong work ethics.
• Ability to manage and treat all team members firmly, fairly, and consistently.
• Strong focus on safety and quality initiatives.
• Demonstrates use of good judgment, ability to maintain confidentiality, and ability to meet deadlines.
• Ability to treat all team members firmly, fairly, and consistently.
• Demonstrated computer skills and proficiency in a Windows operating environment to include word processing and spreadsheet applications as well as Internet and email use.
• Demonstrated ability to communicate effectively, orally and in writing, including ability to translate technical information into lay language and vice versa.
• Ability to establish and maintain effective working relationships across the organization, including outside clients/customers and vendors; including a proven ability to work effectively in a diverse workforce.