Operations Manager

Operations Manager

Location: Alpharetta, GA
Department: Operations
Reports to: Director of Operations & Customer Service

Company Overview

MediVena is an international medical device and healthcare products company headquartered in Atlanta, GA (USA) with European operations in Warsaw, Poland. The company develops, manufactures, and markets innovative, high-quality, and cost-effective medical devices and healthcare consumables for professional and consumer use worldwide.

MediVena operates in a highly regulated ISO 13485 and FDA environment, serving healthcare systems, distributors, and e-commerce channels globally.

Position Overview

MediVena is seeking a highly experienced Operations Manager to lead and optimize Sourcing & Vendor Management, Inventory Control, Receiving, Warehousing, Shipping, and Customer Service operations in a regulated medical device environment.

This role owns the end-to-end operational execution and customer transactional experience, ensuring product availability, regulatory compliance, cost efficiency, and operational excellence. The Operations Manager will be responsible for developing and maintaining processes, procedures, and records under the Quality Management System (QMS), managing in-house resources and external suppliers, and driving continuous improvement across all operational functions.

The ideal candidate is data-driven, process-oriented, and hands-on, with proven experience managing healthcare or medical device operations while balancing quality, cost, speed, and customer satisfaction.

Key Responsibilities1. Supplier Selection, Qualification & Vendor Management

· Establish and maintain supplier qualification and approval criteria in compliance with ISO 13485 and FDA requirements

· Identify and onboard new suppliers through RFQs, cost comparisons, and capability assessments

· Negotiate Supply Agreements and Quality Agreements, including pricing, lead times, MOQs, and service levels

· Optimize international shipping configurations, including 40' High Cube container utilization, to minimize freight cost and maximize efficiency

· Conduct supplier desk audits and on-site audits as required

· Develop, monitor, and report supplier performance scorecards (quality, delivery, responsiveness, cost)

· Maintain complete and traceable supplier documentation and communications in HubSpot CRM and QMS systems

1. Inventory Control, Purchasing & Logistics

· Analyze sales forecasts and historical demand to establish min-max inventory levels and safety stock

· Issue and manage Purchase Orders, ensuring on-time delivery and accurate fulfillment

· Monitor supplier lead times, transit times, and delivery performance

· Coordinate with freight forwarders, customs brokers, and import agencies to ensure compliant and cost-effective logistics

· Proactively mitigate supply risks and prevent stock-outs or excess inventory

1. Receiving, Warehousing & Shipping Operations

· Oversee incoming inspections for product quality, quantity accuracy, shipping damage, and documentation completeness

· Design and continuously improve warehouse layout, including bin locations, staging, quarantine, and shipping areas

· Implement and maintain inventory traceability and automation of records

· Maintain environmental monitoring records (temperature, humidity) and pest-control logs

· Manage over-labeling, rework, and relabeling activities in compliance with regulatory requirements

· Supervise outbound shipping to ensure accurate, timely, and compliant order fulfillment

· Manage customer returns, discrepancies, and corrective actions

· Perform and supervise cycle counts and full inventory reconciliations

· Lead and schedule warehouse staff to meet daily operational demands

1. Order Fulfillment & Customer Service

· Oversee order processing and transactions in QuickBooks

· Supervise Operations & Customer Service Specialists

· Ensure timely and accurate order confirmations, invoicing, and shipping documentation

· Provide escalated customer support as needed

· Manage customer complaints, returns, and service issues in collaboration with QA/RA and Sales teams

1. Operational & Cross-Functional Leadership

· Collaborate closely with Product Management, Sales, Marketing, Finance, and QA/RA teams

· Support regulatory inspections, audits, and compliance initiatives

· Ensure operational readiness for new product launches and market expansions

· Participate in strategic planning and continuous improvement initiatives

1. Financial & Cost Management

· Manage and control the Operations department budget

· Analyze and recommend cost of goods (COGS), pricing tiers, and incentive structures

· Track gross margin performance and identify corrective actions to improve profitability

· Drive cost-reduction initiatives across sourcing, logistics, and warehousing

1. Team Leadership & Development

· Recruit, onboard, mentor, and develop the operations and warehouse team

· Establish clear objectives using Management by Objectives (MBO)

· Define, monitor, and report KPIs and performance metrics

· Foster a culture of accountability, compliance, and continuous improvement

Key Performance Indicators (KPIs)

· Supplier On-Time Delivery: ≥ 95%

· Supplier Quality Performance (Incoming Defect Rate): ≤ 1.0%

· Inventory Accuracy: ≥ 99%

· Order Fulfillment Accuracy: ≥ 99.5%

· Order Cycle Time (Order to Ship): ≤ 24–48 hours (standard orders)

· Stock-Out Rate: < 2%

· Freight Cost as % of COGS: Continuous YoY improvement

· Gross Margin Improvement: YoY improvement vs baseline

· Customer Complaint Rate: ≤ defined internal threshold

· Audit Findings: Zero critical findings; timely closure of non-conformities

Qualifications & RequirementsEducation

· Bachelor's degree in Operations Management, Supply Chain, Engineering, Business, or related field

· Advanced degree or certifications (CPIM, CSCP, Lean, Six Sigma) preferred

Experience

· 5+ years of progressive experience in operations, supply chain, or logistics

· Proven experience in medical device, healthcare, pharmaceutical, or regulated manufacturing environments

· Hands-on experience with ISO 13485 and FDA-regulated operations

· Experience managing international suppliers and global logistics

· Prior warehouse and team leadership experience required

Skills & Competencies

· Strong analytical and data-driven decision-making skills

· Deep understanding of inventory control, purchasing, and logistics

· Experience with QuickBooks, CRM systems (HubSpot preferred), and ERP/QMS tools

· Excellent negotiation and vendor-management skills

· Strong documentation, SOP development, and audit readiness mindset

· Ability to balance strategic planning with hands-on execution

· Excellent communication and cross-functional collaboration skills

What Success Looks Like

Within the first 12 months, the Operations Manager will have: - Established scalable, compliant, and efficient operational processes - Improved supplier performance, inventory accuracy, and fulfillment speed - Reduced freight and operational costs while protecting margins - Built a high-performing, accountable operations team - Delivered a consistently positive customer experience

Pay: $40, $50,000.00 per year

Work Location: In person