Manager, Operations

Secant Group; Quakertown (Bucks County); On-site; USD 90,000 - 120,000; Full time

Job summary

Secant Group is seeking an Operations Manager to plan, supervise, and optimize manufacturing operations for Medical Component and Technical Textile lines. You will work with engineering, quality, and product development to drive efficiency, productivity, and profitability while meeting customer commitments.

The role emphasizes achieving monthly and annual goals, adherence to regulatory standards, and collaboration with senior leadership to improve processes and implement CAPA-driven improvements.

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 ability to enforce them.

Responsibilities

• Manages operations functions within Medical Component and Technical Textile manufacturing operations, supervising supervisors, engineers, and leads.
• Ensures resources are used efficiently, schedules optimized, and on-time delivery to specifications.
• Improves processes and policies to maximize output and aligns with organizational goals.
• Monitors adherence to rules to achieve monthly, quarterly, and annual goals.
• Ensures products are manufactured and shipped according to production plans and quality standards.

Skills

Leadership

Operations management

Regulated manufacturing

ERP systems

Microsoft Office

Education

Bachelor’s degree in engineering/operations

Tools

ERP systems

Job description

What We Are Looking For

The Operations Manager plans, manages, and supervises various activities related to manufacturing operations to ensure customer commitments are met. The incumbent works closely with the Sr. Director of Operations, Manufacturing Engineering, Quality Engineering, and Product Development Engineering to drive improved performance, productivity, efficiency, and profitability. This position establishes tactical plans to align and execute strategic objectives, focusing on operational efficiencies and customer deliverables.

What You Will Do

• Manages operations functions within Medical Component and Technical Textile manufacturing operations, as assigned. This includes the direct supervision of Operation Supervisors, Engineers, and Group Leads in said defined areas
• Ensures effective utilization of resources, proper documentation, efficient scheduling, and on-time delivery of products to specifications to ensure all internal and external customer needs are met.
• Improves processes and policies in support of organizational goals. Formulates and implements departmental and organizational policies and procedures to maximize output.
• Monitors adherence to rules, regulations, and procedures to achieve monthly, quarterly, and annual goals.
• Ensures product are manufactured and shipped according to the production plan of good quality and in support of monthly goals. Establishes and uses metrics to conduct process and trend analysis.
• Identifies equipment and capital investments required to support business requirements and provides feedback to Director of Operations in this regard.
• Supports R&D initiatives and works with engineering team to manufacture trial designs.
• Interacts with Leadership team, Manufacturing, Quality, and Product Development Engineering to ensure the continuous improvement of existing manufacturing processes, the cost efficient and effective creation of new processes, and the accurate and timely resolution of manufacturing and product quality issues.
• Supports the company Quality Management System(s) and ensures production adheres to all regulatory and quality requirements. Adheres to ISO 13485, Good Manufacturing Practices (GMP) and safety requirements.
• Supports collaborative CAPA Quality root-cause analysis, identifies, and implements resolution to improve overall quality and performance of the products being delivered to our customers.
• Works closely with Quality Assurance to ensure the manufactured products meet internal specifications and participates in meetings with customers, audits, and CAPA resolution. Ensures compliance with Quality System requirements including calibration, preventive maintenance, and corrective action.
• Provides recommendations on staffing requirements, participates in the selection and hiring process; interviews applicants and makes hire recommendations
• Works with Finance financial planning and management including, capital expenditures, resource planning, budgeting, and cost control.
• Jointly works with Sr. Director of Operations on the execution of corporate goals and objectives in support of yearly budgets. Provides input during the department budgeting process and monitors and controls expenses through the year to meet budget requirements
• Works closely with Human Resources to Ensure annual Organization Resource Development plans are in place, including individual development plans. A key to success in this role is involvement with the hourly workforce in all aspects of manufacture.
• Identifies staffing requirements, participates in the selection and hiring process; interviews applicants and makes hire recommendations.
• Provides coaching, feedback, and guidance to team members on a continual basis and takes an active role in developing, monitoring, and updating a career plan for advancement.
• Completes performance appraisals and reviews with employees; recommends salary increases to management and HR.
• Provides input to the department budgeting process and monitors and controls expenses through the year to meet budget requirements.

Who You Are

• 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 machinery, equipment, tools, and textile equipment in support of yarn preparation operations, specifically as it applies to winding, twisting, direct and indirect warping
• Possess 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.