Assembler/Sewer/Sewist - For Medical Device

PURPOSE OF JOB:

Responsible for assembly and production of medical devices based company requirements

while adhering to FDA GMPs, ISO, and Corporate Quality Systems regulations. Works closely with Supervisor to adhere to safety and cleanliness practices in the work place. Performs sewing, assembling and sampling of components and/ or finished medical devices in controlled environment.

MAJOR DUTIES AND RESPONSIBILITIES:

• Sewist: assembles and sew components of the ear dressing into medical devices in accordance with approved manufacturing procedures. May perform simple visual inspection of the components or the assembly.
• Performs inspections on sub-assemblies and finished product acccording to well defined criteria using visual standards.
• Utilizes the sewing machines and accessories in the manufacturing of the medical devices.
• Maintains CE room accessories, such as sewing machine, and or any other equipment in the control environment.
• Maintains clean work environment integrity by using proper attire and adherence to cleaning practices and procedures.
• Adheres to general safety rules, company policies and procedures, ISO, and FDA GMPs regulations.
• Maintains acceptable level of productivity.
• Performs other duties as assigned.

EDUCATION AND EXPERIENCE REQUIREMENTS:

High school diploma or equivalent required.

Sewist must be able to use and perform simple sewing activities.

OTHER QUALIFICATIONS:

· Knowledge – Must be able to read/write English and have basic math skills. Must be able to read blueprints.

• Mental - Requires a relatively high degree of concentration and attention to detail.
• Physical - Requires walking/standing approximately 5% of time; sitting approximately 95% of time; lifting up to 25 lbs. approximately 15% of time; stooping, forward bending and crouching approximately 5% of time.
• Environmental - Requires capability of performing essential job functions in a production environment with climate-control and good lighting.
• Manual Dexterity - Requires use of hands and arms to operate sewing equipment, clean work area, and to record written information. Must be able to work with small parts.
• Audible - Requires the ability to verbally communicate with supervisor and co-workers.

Job Type: Full-time

Pay: From $15.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Work Location: In person

Salary : $15