Operations Manager

As the Operations Manager, you will be responsible for overseeing and optimizing day-to-day operational activities within a regulated life sciences environment. This role ensures efficient, compliant, and scalable operations while maintaining adherence to FDA medical device regulations and ISO 9001 quality management system requirements. You must bring strong leadership, process improvement expertise, and a deep understanding of regulated manufacturing or product development environments.

• Lead and manage daily operational functions including manufacturing, supply chain, logistics, and vendor management
• Ensure full compliance with FDA medical device regulations (e.g., 21 CFR Part 820) and applicable international standards
• Maintain, support, and continuously improve the ISO 9001 Quality Management System (QMS)
• Partner with Quality, Regulatory Affairs, and Engineering teams to support audits, inspections, and regulatory submissions
• Develop, implement, and optimize standard operating procedures (SOPs) to improve efficiency and ensure compliance
• Monitor operational KPIs and drive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies
• Oversee capacity planning, inventory control, and cost management to support business growth
• Manage and develop cross-functional teams, fostering a culture of quality, accountability, and continuous improvement
• Support risk management, corrective and preventive actions (CAPA), and root cause analysis activities
• Collaborate with senior leadership on strategic planning and operational scaling initiatives

• Bachelor’s degree in Engineering, Life Sciences, Operations Management, or a related field (Master’s preferred)
• 5+ years of operations management experience in a life sciences or medical device environment
• Demonstrated experience working with FDA medical device regulations (21 CFR Part 820 required)
• Hands‑on experience maintaining or implementing an ISO 9001 certified Quality Management System
• Strong understanding of regulated manufacturing, quality systems, and supply chain operations
• Proven leadership and people management experience
• Excellent problem‑solving, organizational, and communication skills
• Experience supporting FDA or third‑party audits strongly preferred

• Experience with additional standards such as ISO 13485 or MDSAP
• Lean Manufacturing or Six Sigma certification
• ERP/MRP system experience
• Ability to thrive in a fast-paced, growth‑oriented environment

• Opportunity to make a direct impact in a growing life sciences organization