Manufacturing Manager (Medical Devices)

Title : Manufacturing Manager

Location : 100% onsite in Baltimore, MD

Direct Hire - Full Time

Position Summary

The Manufacturing Manager oversees the day-to-day operations of IVD product manufacturing, ensuring production activities are executed safely, efficiently, and in compliance with ISO 13485, FDA 21 CFR Part 820 (QSR), and IVDR requirements. This role is responsible for managing production teams, maintaining product quality, meeting output goals, and supporting continuous process improvements to ensure the reliable supply of high-quality diagnostic products.

Key Responsibilities

• Lead and manage manufacturing operations for IVD products, including reagents, consumables, and diagnostic kits.
• Oversee the end-to-end manufacturing of plastic cartridges, from raw material handling and injection molding to automated assembly, inspection, and packaging.
• Plan, schedule, and coordinate production activities to meet customer demand, quality standards, and on-time delivery targets.
• Ensure compliance with ISO 13485, FDA QSR (21 CFR Part 820), IVDR, GMP, and other applicable regulatory requirements.
• Develop, implement, and monitor manufacturing procedures, batch records, and work instructions.
• Oversee training, development, and performance management of manufacturing staff to ensure competency and compliance.
• Collaborate with Quality Assurance, Quality Control, R&D, and Supply Chain to support new product introduction, technology transfer, and process scale-up.
• Monitor and analyze production metrics (yield, throughput, scrap rate, deviations) to drive operational efficiency and continuous improvement.
• Lead investigations into deviations, nonconformances, and complaints; implement corrective and preventive actions (CAPAs).
• Ensure manufacturing equipment is maintained, calibrated, and qualified per quality system requirements.
• Support audits and inspections by regulatory authorities and notified bodies.
• Drive a culture of safety, compliance, and operational excellence within the manufacturing team.

Qualifications

Preferred Skills

Working Conditions