Job Title: Operations Manager

Location: Atlanta

Reports To: CEO

Department: Operations / Manufacturing

Job Summary

We are seeking a highly organized and results-driven Operations Manager to oversee and streamline our medical device manufacturing operations. This role is responsible for end-to-end production planning, procurement, ERP utilization, process improvement, and vendor management, including contract manufacturing. The ideal candidate will play a critical role in ensuring efficient, compliant, and cost-effective operations while supporting cross-functional teams in sustaining engineering and design transfer activities.

Key Responsibilities

• Production Planning: Develop and manage production schedules to meet demand forecasts, inventory targets, and customer delivery timelines.
• Purchasing & MRP: Oversee procurement of raw materials and components in alignment with MRP requirements. Maintain optimal inventory levels and vendor relationships. Issue purchase orders, consign inventory, and establish and track delivery timelines.
• ERP System Management: Use and improve ERP system functionality for production, inventory, purchasing, order fulfilment, and reporting.
• Process Development & Improvement: Identify and implement continuous improvement initiatives in manufacturing processes to increase efficiency, reduce costs, and maintain compliance with quality standards.
• Troubleshooting: Address operational issues, root cause analysis, and implementation of corrective and preventive actions (CAPA).
• Design Transfer: Collaborate with R&D to transition new products into manufacturing, ensuring processes are validated, documented, and compliant with regulatory requirements.
• Vendor & Contract Manufacturing Management: Establish and manage strong relationships with suppliers and contract manufacturers. Monitor performance, negotiate contracts, and ensure quality and on-time delivery.
• Key Performance Indicators (KPIs): Establish, track, and report on KPIs for manufacturing, quality, and supply chain metrics. Use data to drive decisions and improvements.
• Training: Train and develop production staff on standard operating procedures (SOPs), safety protocols, and quality standards.
• Sustaining Engineering: Support ongoing engineering changes, product improvements, and cost reductions in collaboration with design and quality teams.
• Non-Conformance Reporting (NCR): Lead the investigation and resolution of NCRs in manufacturing. Implement corrective actions and monitor effectiveness.
• Compliance: Ensure all operations adhere to FDA 21 CFR Part 820, and other applicable regulations and standards.

Qualifications

• Bachelor’s degree in Engineering, Operations Management, Supply Chain, or a related field. Master’s degree or MBA is a plus.
• 5–10 years of operations or manufacturing management experience in the medical device space.
• Strong understanding of GMP, ISO 13485, FDA QSR, and other regulatory requirements.
• Experience with ERP/MRP systems
• Proven ability to lead cross-functional teams and drive operational excellence.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication, organizational, and project management abilities.

Preferred Skills

• Six Sigma or Lean Manufacturing certification.
• Experience with new product introductions (NPI) and design transfer.
• Familiarity with quality tools: FMEA, CAPA, Root Cause Analysis, etc.
• Proficiency with data analysis tools (Excel, Power BI, etc.).

This job description is not exhaustive and may have been condensed for online or mobile viewing. It does not encompass all duties, responsibilities, or aspects of the job, and is subject to amendments at the sole discretion of the Employer. Employees may also perform other related duties as negotiated to meet the organization’s ongoing needs. 

Legacy MedSearch was named to the 2019-2024 Forbes list of Best Recruiting Firms in America.