Clean Room Assembler

Sterling-Industries-4; Texas Charter Township (MI); On-site; USD 40,000 - 56,000; Full time

Job summary

Sterling Industries in Michigan specializes in medical device contract manufacturing. We are seeking experienced Clean Room Operators with ISO13485 experience to ensure products meet specifications, on time, and within budget.

You will coordinate with manufacturing, quality, and engineering teams, maintain GMP compliance, and drive improvements in processes and equipment. A minimum of five years in manufacturing and proficiency with ERP/MRP systems is preferred.

Qualifications

• Minimum 5 years in a manufacturing environment (production, equipment, quality systems, facility).
• Experience in GMP and ISO13485 environments.
• Proficient with Microsoft Office suite (Outlook, Word, Excel).

Responsibilities

• Ensure GMP is followed at all times and resources are used efficiently.
• Meet budgeted costs for labor, materials, equipment, and related expenses.
• Maintain compliance with quality management system and ISO13485.
• Perform inspections (receiving, in-process, final) and document results.
• Use ERP/MRP systems to schedule production resources.
• Perform preventative maintenance and resolve equipment issues per QMS.
• Drive continuous improvement in people, equipment, processes, products, and facilities.
• Minimize and resolve quality issues with the quality department.
• Maintain cleanliness of the production area and related documentation.

Skills

5+ years manufacturing experience

GMP compliance

ISO13485 experience

Dexterity

Microsoft Office proficiency

Job description

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)
• 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 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.

6am - 2pm Mon- Fri. with Overtime when needed