About the role
About us: Sterling Industries is a North American based contract manufacturer and assembler of medical devices and sub-components. We help clients deliver successful products by providing scaled production, design-for-manufacturing expertise, supplier consolidation and other critical value chain services.
Overview
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
J. Sterling Industries is an equal opportunity employer. If you require accommodation, please notify us and we will work with you to meet your needs.
About Sterling Industries
Sterling Industries is a vertically integrated contract manufacturer of medical devices and medical device components with facilities in both the US and Canada. We help companies — from Fortune 100 to mid-size to start-up — scale from launch to full production (whether it be from thousands to millions of units), with consistent and immaculate quality, process and compliance. We offer a repeatable design transfer process, design-for-manufacturing expertise, regulatory compliance and supply chain optimization. Our company mantra is: 100% on time, 100% complete and 100% quality. We manufacture success.
Whether your device requires complicated machined components, intricate injection molded parts, laser cut small diameter stainless steel tubing, laser cut large format metal, robotically welded pieces, integrated electronics, ultrasonic welded parts, and/or low pressure over-molding, our team of engineers, designers and technicians can help make your product a reality. We assemble your device in a Class 7 Clean Room, a White Room or on the Shop Floor as required.
We are ISO 13485:2016 Certified and 21 CFR Part 820 Compliant and are FDA and Health Canada Registered. Let's discuss your project. Contact us by email at sales@sterlingindustries.com or call us toll-free at 1 (888) 669-0246.
About the role
About us: Sterling Industries is a North American based contract manufacturer and assembler of medical devices and sub-components. We help clients deliver successful products by providing scaled production, design-for-manufacturing expertise, supplier consolidation and other critical value chain services.
Overview
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
J. Sterling Industries is an equal opportunity employer. If you require accommodation, please notify us and we will work with you to meet your needs.
About Sterling Industries
Sterling Industries is a vertically integrated contract manufacturer of medical devices and medical device components with facilities in both the US and Canada. We help companies — from Fortune 100 to mid-size to start-up — scale from launch to full production (whether it be from thousands to millions of units), with consistent and immaculate quality, process and compliance. We offer a repeatable design transfer process, design-for-manufacturing expertise, regulatory compliance and supply chain optimization. Our company mantra is: 100% on time, 100% complete and 100% quality. We manufacture success.
Whether your device requires complicated machined components, intricate injection molded parts, laser cut small diameter stainless steel tubing, laser cut large format metal, robotically welded pieces, integrated electronics, ultrasonic welded parts, and/or low pressure over-molding, our team of engineers, designers and technicians can help make your product a reality. We assemble your device in a Class 7 Clean Room, a White Room or on the Shop Floor as required.
We are ISO 13485:2016 Certified and 21 CFR Part 820 Compliant and are FDA and Health Canada Registered. Let's discuss your project. Contact us by email at sales@sterlingindustries.com or call us toll-free at 1 (888) 669-0246.