Operations Manager

Custom Medical Specialties, Inc.; Pine Level (NC); On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

Competitive salary

Performance-based bonuses

Collaborative team environment

Job summary

A medical device manufacturer in Pine Level, NC is seeking an experienced Operations Manager to enhance production efficiency and drive operational excellence. The ideal candidate will have over 5 years in operations management, ideally within regulated environments, and possess strong leadership and analytical skills. This full-time role offers a competitive salary and the chance to impact strategic operations in a stable, growing company.

Qualifications

• 5+ years of experience in operations or production management, preferably in medical devices.
• Solid understanding of ISO 13485 and FDA QSR requirements.
• Strong leadership presence with coaching abilities.

Responsibilities

• Oversee day-to-day operations including production scheduling and inventory management.
• Lead and develop a team of supervisors and staff.
• Implement SOPs aligned with ISO 13485 and FDA QSR.

Skills

Analytical skills

Leadership

Communication skills

Problem-solving abilities

Proficiency with Excel

Education

Bachelor’s degree in Operations Management or related field

Tools

NetSuite

ERP systems

Job description

Overview

Full-Time | On-Site | $85,000–$95,000 per year (based on experience)

Custom Medical Specialties (CMS) is a U.S.-based contract manufacturer specializing in disposable medical devices, including custom tubing sets, drain bags and procedure trays. All products are assembled, packaged, and sterilized in our ISO 8 cleanrooms at our Pine Level, North Carolina facility. CMS is FDA-registered and ISO 13485-certified, maintaining the highest standards of quality, precision, and compliance. Our customers include OEMs, hospitals, and distributors across multiple healthcare markets. We are seeking a proven Operations Manager to help drive efficiency, growth, and operational excellence.

About the Role

The Operations Manager will lead CMS’s daily manufacturing, warehouse, and logistics operations. This role is central to the company’s continued growth — the selected candidate will directly influence production efficiency, cost control, and delivery performance across multiple medical device product lines. We’re looking for a hands-on, data-driven leader who thrives in a fast-paced environment and can balance floor-level management with strategic planning and process improvement.

Key Responsibilities

• Oversee all day-to-day operations, including production scheduling, assembly, and inventory management.
• Lead and develop a team of supervisors, assemblers, and warehouse staff — setting clear expectations and fostering accountability.
• Implement and maintain SOPs aligned with ISO 13485 and FDA QSR requirements.
• Optimize material flow, production throughput, and overall equipment utilization.
• Collaborate with Quality, Engineering, and Supply Chain to resolve nonconformances and customer issues.
• Manage vendor relationships and ensure on-time delivery of critical components.
• Track and analyze production KPIs (throughput, yield, lead time, and scrap) to drive measurable improvements in cost and efficiency.
• Support ERP (NetSuite) and EazyStock workflows for accurate inventory and BOM management.

Qualifications

• Bachelor’s degree in Operations Management, Business Administration, or Engineering (preferred).
• Minimum 5 years of experience in operations or production management; medical device or regulated manufacturing experience strongly preferred.
• Solid understanding of ISO 13485, FDA QSR, and cGMP requirements.
• Strong analytical and problem-solving abilities; proficiency with Excel and ERP systems (NetSuite experience a plus).
• Strong leadership presence with the ability to coach teams, establish goals, and build accountability.
• Excellent communication skills and comfort working cross-functionally.

Why Join CMS

• Competitive salary with potential for performance-based bonuses.
• Join a stable, fast-growing medical device manufacturer with U.S.-based cleanroom production.
• Opportunity to shape operational systems and influence company-wide success.
• Collaborative, team-oriented environment where your ideas have a direct impact on outcomes.
• Be part of a company that values reliability, innovation, and continuous improvement.

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