Description:
We are seeking experienced Clean Room Operators with experience in the medical device manufacturing industry (ISO13485). The Clean Room Operator ensures optimal use of company resources (people, materials, equipment) to produce products to specification, on time, and complete to meet or exceed the expectations of our customers while improving our people, processes, and equipment.
Key Responsibilities Include:
Ensuring GMP are being followed at all times
- Ensuring optimal use of company resources
- Responsible for meeting budgeted costs for labor, material, equipment, and other production related expenses
- Ensuring all production related processes, documentation and areas are in compliance with our quality management system and ISO13485
- Participates in performing inspections for receiving, in-process and final inspections.
- Use of ERP/MRP systems in scheduling production people, materials and equipment to ensure optimal use of company resources
- Ensuring preventative maintenance and resolution of equipment issues are performed in accordance with the quality management system
- Driving continuous improvements in people, equipment, processes, products, and the facility as per Quality Objectives and departmental activities.
- Minimizing and resolving quality issues while working in conjunction with the quality department
- Responsible for cleanliness of the production area and all related documentation
Position Requirements
- Ideal candidate has a minimum of 5 years of experience in a manufacturing environment (production, equipment, quality systems, and facility)
- Has good dexterity
- Able to communicate and coordinate with administrative, operations, quality, and engineering teams
- Able to implement, and complete continuous improvement efforts
- Able to work a flexible schedule
- Has extensive working knowledge of manufacturing and process equipment
- Proficient in Microsoft Office (outlook, word, excel) an asset
- Experience in clean room environment and ISO13485 standard