Job Summary:
The role of the Quality Control Technician is to perform and ensure the product documentation is complete, accurate and compliant to the ISO 13485 standards and FDA regulations.
Duties/Responsibilities
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Understand, support, and comply with the Company Quality System requirements.
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Maintain a safe and clean work environment.
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Follow the standard operating procedures and written work instructions.
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Openly communicate with the Company team members.
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Perform Device History Record (DHR) review for production and RGA products.
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Perform label inspection on product labeling.
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Generate product Certificate of Conformance (C of C) documents for production and RGA.
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Perform final acceptance of product before customer shipment
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Review sterilization process data and reports for compliance.
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Identify and support continuous improvement efforts with Supervisor.
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Take on special projects as assigned.
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Other duties as assigned.
Other duties
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Verifies work affecting quality independently and has the authority to perform these tasks as stated in the responsibilities section.
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Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Qualifications:
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3-5 years in a regulated manufacturing environment, experience in an ISO 13485:2016 manufacturing environment is preferred.
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Strong mechanical aptitude abilities.
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Ability to communicate effectively through oral and written communications.
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Ability to work with others collaboratively.
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Attention to detail to understand and meet the requirements.
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Strong organizational skills.
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Strong verbal communication skills.
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Demonstrated problem solving ability in a cross functional environment.
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Take responsibility for task and time management.
Physical Requirements:
This position requires working in an office setting. This includes sitting at a desk working on a computer
for long periods of time. It also could include lifting 40 pounds and standing for long periods of
time as well as walking the facility.
On-Site/Remote Attendance: This position requires 100% on-site attendance.
