The APO Manager provides direct management of supervisors, leads, technicians, and operators. Allocates resources based on departmental plans & budgets. Responsible for hire/fire decisions within their department. Submits performance/productivity targets, and reports on results. Measured against performance plan goals and objectives. Responsible for departmental performance. The primary role of the APO Manager is to plan, organize and control production to ensure safe, efficient, and effective operation and that all products are produced efficiently, on time, within budget, and to standard.

Duties and Responsibilities:

Develops production schedules in conjunction with the Director of Operations; plans, directs, and assigns duties for manufacturing personnel.

· Recruits, hires, and trains employees on manufacturing functions; conducts safety orientations and meetings; assures that established policies and procedures are followed.

· Coordinates with the Engineering Manager for the development of manufacturing methods, processes, tooling, and molds necessary to produce new products.

· Oversee and supervise all functions including receiving components onto the production floor, inventory control, production, and interim quality checks, and assure compliance with all regulations and good manufacturing practices.

· Troubleshoots any production problems; assures that machinery, equipment, and facilities are properly maintained for efficient production; reports any process or equipment problems to the Director of Operations.

· Drives manufacturing performance by directing all APO production in the plant, to meet schedules that allow for superior customer satisfaction and high plant efficiency by establishing and executing operating plans and objectives.

· Provide plant floor supervision and leadership to ensure compliance with all company quality standards.

· Staff, manage, coach, motivate, train, and assess the performance of production and operations employees, both exempt and nonexempt by reviewing the performance of staff and organizing necessary actions for improvement.

· Performs other manufacturing duties as required.

Required Qualifications:

Must be Bilingual (English & Spanish)
5+ years of progressive manufacturing leadership experience in an FDA regulated medical device environment, including 3+ years of managing others.
Understanding of medical device manufacturing requirements, specifically knowledge of current ISO and FDA requirements.
5+ years’ experience with all phases of the assembly/packaging development and lifecycle, including concept, design, implementation, verification, root cause analysis, validation activities and troubleshooting skills necessary for product commercialization in a medical device environment.
Extensive experience in GDP/GMP and other production-centric regulatory compliance requirements.
Knowledge of equipment and auxiliary equipment maintenance and repair requirements.

Preferred Qualifications:

· Experience and competence in reading and understanding drawings, specifications, and performance requirements.

· Lean manufacturing experience.

Physical/Mental Demands

· Physical activity includes walking, standing, bending, squatting, reaching above shoulders, and lifting to 40 lbs.

· Performs primarily activities in a clean room environment. May be subject to changes in temperature and exposure to dust. Will work in a normally acceptable office environment, production floor, or warehouse, with no abnormal hazards or risks.

International Medical Industries jobs

Assembly and Packaging Operations Manager