Operations Leader - Medical Manufacturing & Quality Excellence

Secant-Group,-LLC; Quakertown (Bucks County); On-site; USD 90,000 - 130,000; Full time

Job summary

Secant Group, LLC seeks an Operations Manager to plan, manage, and supervise manufacturing activities across Medical Component and Technical Textile operations. You will partner with Manufacturing Engineering, Quality, and Product Development to drive efficiency, meet customer commitments, and lead process improvements.

The role requires strong leadership, hands-on supervision of engineers and leads, and a deep knowledge of manufacturing workflows and ERP systems.

Qualifications

• Bachelor’s degree in engineering discipline, operations management, or industrial engineering.
• 5 years previous experience in similar role within a regulated manufacturing environment.
• Demonstrated leadership skills and the ability to coach and mentor staff.
• Must have considerable knowledge of manufacturing processes.
• Knowledge of ISO 13485, 9001 and GMP practices or possess the ability to understand and enforce the practices.
• Ability to follow and make recommendation and changes to WI’s and SOP’s.
• Ability to measure in all units of measurements and possess a high mathematical aptitude.
• Considerable knowledge of ERP systems and the manufacturing workflow.
• Considerable knowledge of the Microsoft Suite of products, specifically Excel, Word, and Outlook.
• Good presentation skills and the ability to present on a one-to-one basis and to small groups.

Responsibilities

• Plans, manages, and supervises manufacturing operations to meet customer commitments.
• Works with Sr. Director of Operations and engineering teams to improve performance, productivity, and profitability.
• Establishes tactical plans aligned to strategic objectives and monitors monthly/quarterly/annual goals.
• Ensures on-time delivery and compliance with quality specifications and production plans.
• Uses metrics for process and trend analysis and guides capital investments.
• Supports R&D initiatives and collaboration with engineering for trial designs.
• Ensures adherence to ISO 13485, GMP, and safety requirements.
• Supports CAPA to analyze root causes and implement corrective actions.
• Participates in audits, customer meetings, and quality system compliance.
• Involves HR in staffing decisions and supports budgeting and cost-control.

Skills

Leadership

Coaching/mentoring

Manufacturing processes

Presentation skills

Mathematical aptitude

Collaboration

Education

Bachelor’s degree in engineering/operations/industrial engineering

Tools

ERP systems

Excel

Word

Outlook

Job description

Secant Group, LLC seeks an Operations Manager to plan, manage, and supervise manufacturing activities across Medical Component and Technical Textile operations. You will partner with Manufacturing Engineering, Quality, and Product Development to drive efficiency, meet customer commitments, and lead process improvements.

The role requires strong leadership, hands-on supervision of engineers and leads, and a deep knowledge of manufacturing workflows and ERP systems.