Assembler

Job description

JOB DESCRIPTION:

MAIN PURPOSE OF ROLE

With minimal supervisory direction, The Assembler II  follows established procedures and quality standards to assemble mechanical, electrical, and/or electronic components, and performs testing and calibration activities to ensure the accuracy and reliability of the assemblies, sub-assemblies, and instruments. Works to achieve a daily build goal in accordance with the manufacturing schedule. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards are mandatory.

MAIN PURPOSE OF ROLE

• Follows standard operating procedures (SOPs) and work instructions to perform wiring, component installation, cable harnessing, fitting of assembly  instruments, etc. using hand and power tools, limited automated equipment, manufacturing aides/fixtures, lifts/cranes, and other methods within the manufacturing process. The Assembler II is a progression role building assemblies that require more components, processes, and precision. Cross trained on instrument assembly build.
• Performs testing, calibration, and verification activities to ensure the accuracy, precision, and reliability of the instruments, and documents the results accurately and timely
• Inspects and verifies the quality of components and finished products to ensure they meet specifications and comply with regulatory requirements, such as FDA guidelines and ISO standards.
• Troubleshoots and resolves production issues or discrepancies. Collaborates with other departments, such as engineering, quality, business excellence, and product development, to provide feedback on product design, manufacturability, process improvements. Also collaborates with cross-functional teams such as engineers, quality assurance, and production supervisors to ensure smooth production flow
• Documents and records production activities, including assembly processes, product information, material control of critical parts, labeling activities, and quality non-conformance, accurately and timely. Actively works to achieve successful first-time right completion of documentation.
• Follows company policies, procedures, and regulations, including quality management systems (QMS), and contributes to maintaining a culture of quality, compliance, and continuous improvement.
• Follows good manufacturing practices (GMP), and complies with safety regulations to ensure a safe and productive work environment.
• With proven efficiency and demonstrated ability, this role may be required to train other assemblers. Specific job function may change. Required to perform other duties as assigned.

Education Level    
High School Diploma / GED

Experience  
Minimum 2 years    

Experience Details

related experience Medical device or diagnostics industry preferred

Familiarity with FDA regulations, ISO standards, and other relevant industry requirements is a plus

Strong technical skills in assembly, testing, and calibration of mechanical, electrical, and/or  electronic components

Ability to interpret and understand technical drawings, instructions, and specifications to complete tasks

Proficient in using hand and power tools such as screwdrivers, wrenches, power drivers, measuring equipment, etc.

Detail-oriented with a high degree of accuracy and precision in work

Strong verbal and written communication skills

 Working knowledge of standard computer programs. Basic mathematical comprehension (addition, subrtaction, multiplication, etc.)

Ability to work independently or as part of a team in a fast-paced, deadline-driven environment.

Good hand-eye coordination skills and mechanical aptitude. Able to lift 50 lbs or more

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Manufacturing

     

DIVISION:

HIAC Core Lab

        

LOCATION:

China > Hangzhou : #198 12th Street, Hangzhou Economic & Technological Development Area

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable