Operations ManagerCustom Medical Specialties, Inc. • Pine Level, NC, United States
Operations Manager
Custom Medical Specialties, Inc. • Pine Level, NC, United States
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job_description.job_card.job_descriptionBachelor’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. 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.
Job Description
Full-Time | On-Site | $85,000–$95,000 per year (based on experience)
About the Company
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. As we continue to expand our manufacturing capabilities and product portfolio, we’re 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
Why Join CMS
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Operation Manager • Pine Level, NC, United States
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