Quality Records Specialist

NextPhase Medical Devices LLC•Mansfield, MA

5d•$22 - $25•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

experience in an ISO 13485:2016 manufacturing environment is preferred.

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