Operations Manager

ATL Technology is seeking a hands-on Operations Manager to oversee day-to- day manufacturing operations. The manager will be responsible ensuring production of high-quality medical devices and components in compliance with regulatory standards (FDA, ISO 13485), optimizing processes, managing teams and meeting production targets. This role requires an individual with strong leadership, organization and problem-solving skills, who is dedicated to driving to operational efficiency, quality control and overall customer satisfaction.  

Key Responsibilities:

• Production Management: Oversee the entire production process, from raw materials to finished products. Ensure that production targets, schedules, and budgets are met while maintaining high quality standards.

• Quality Assurance & Compliance: Ensure all manufacturing activities comply with FDA regulations, ISO 13485, and other relevant industry standards. Coordinate with the Quality Assurance team to enforce strict quality control measures across the production process.

• Process Optimization: Continuously assess and improve manufacturing processes to enhance efficiency, reduce waste, and lower costs. Implement Lean and Six Sigma methodologies to optimize operations.

• Team Leadership & Development: Manage, train, and develop a high-performing production team. Promote a culture of teamwork, accountability, and continuous improvement.

• Supply Chain & Inventory Management: Oversee raw material procurement, inventory control, and supplier management to ensure smooth production flow and timely delivery of products to clients

• Budget & Cost Control: Develop and manage departmental budgets. Monitor operational costs and implement cost-saving initiatives while maintaining high-quality standards.

• Health and Safety Compliance: Ensure that the manufacturing facility adheres to all health, safety, and environmental regulations. Foster a safe working environment and drive safety initiatives.

• Reporting & Documentation: Maintain accurate production records, including batch logs, production reports, and compliance documentation. Provide regular updates to senior management on operational performance, challenges, and achievements.

Qualifications:

• Education: Bachelor's degree in engineering, manufacturing, operations management, or related field. 

• Experience: Minimum of 5-7 years of experience in operations management, with at least 3 years in a medical device manufacturing environment or regulated industry.

• Technical Skills: Proficiency in ERP systems (e.g., SAP, Oracle, Infor), and MS Office Suite. Knowledge of Lean, Six Sigma, and other process improvement methodologies.

• Regulatory Knowledge: In-depth understanding of FDA regulations, ISO 13485, and GMP guidelines.

• Leadership: Proven ability to lead and manage cross-functional teams, with strong interpersonal and communication skills.

• Problem Solving: Strong analytical and problem-solving skills, with a proactive approach to addressing operational issues.

• Project Management: Experience managing projects from concept to completion, with the ability to prioritize tasks and manage multiple deadlines effectively.

• Flexibility: Ability to adapt to changing requirements, customer needs, and market conditions.

Desired Skills:

• Experience in medical device sterilization processes (e.g., EO, gamma, autoclave).

• Familiarity with FDA design controls and risk management processes.

• Strong understanding of the supply chain and logistics within the medical device manufacturing industry.

• Experience working in a contract manufacturing organization (CMO).