Quality Records Specialist

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

• Understand, support, and comply with the Company Quality System requirements.
• Maintain a safe and clean work environment.
• Follow the standard operating procedures and written work instructions.
• Openly communicate with the Company team members.
• Perform Device History Record (DHR) review for production and RGA products.
• Perform label inspection on product labeling.
• Generate product Certificate of Conformance (C of C) documents for production and RGA.
• Perform final acceptance of product before customer shipment
• Review sterilization process data and reports for compliance.
• Identify and support continuous improvement efforts with Supervisor.
• Take on special projects as assigned.
• Other duties as assigned.

Other duties

• Verifies work affecting quality independently and has the authority to perform these tasks as stated in the responsibilities section.
• 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:

• 3-5 years in a regulated manufacturing environment, experience in an ISO 13485:2016 manufacturing environment is preferred.
• Strong mechanical aptitude abilities.
• Ability to communicate effectively through oral and written communications.
• Ability to work with others collaboratively.
• Attention to detail to understand and meet the requirements.
• Strong organizational skills.
• Strong verbal communication skills.
• Demonstrated problem solving ability in a cross functional environment.
• 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.