Quality Specialist - 1st Shift

EPTAM Plastics•Northfield, NH

3d•$19 - $25•Onsite

About The Position

EPTAM Precision is looking for a Quality Specialist - 1st Shift to join their team in Northfield, NH. This role involves supporting customer quality paperwork shipping requirements and ensuring the quality of parts produced for the medical industry. EPTAM Plastics, founded in 1981, is a leader in plastic component manufacturing and CNC machining, specializing in complex multi-axis plastic machining and metrology. They are an FDA-registered, ISO 13485 certified company that emphasizes quality and innovation in serving sectors like biopharma, molecular diagnostics, and implantable devices.

Requirements

Three (3) years’ experience in a manufacturing environment, equivalent combinations of education and experience accepted OR demonstrated ability to execute the Essential Functions for this position.
Internships and PT experience acceptable.

Nice To Haves

High School diploma, general education degree (GED) and/or trade school graduate preferred.

Responsibilities

Compare print requirements with parts produced to determine the final quality of part for customer requirements of Quality Shipping paperwork.
Perform FAI (First Article Inspection) reviews and the completion of the applicable FAI requirements based on customer requirements.
Work with applicable Sales team members to assist with FAI submittals, if required.
Develop, review, and approve Quality document packages for shipping purposes.
Organize, compile, complete, and approve all necessary MDHR (Medical Device History Records)/DHR (Device History Records) for conformance before product shipment and scanning electronically to file and logging for storage purposes.
Ability to work with outside storage facilities to recall and request services in relation to our company’s MDHR/DHR needs.
Assist with customer and system related audits as it relates to raw material RTI (Receive to Inspect), FAI, MDHR/DHR requirements and Quality Shipping Paperwork.
Compile, complete, and understand CTQ (Critical to Quality) data requirements, if required.
Review customer PO for proper adherence to all requirements prior to shipment.
Perform in-depth review of all paperwork, marked parts, bagged parts, etc. for accuracy prior to shipment.
Generate daily report of GDP (Good Documentation Practice) errors identified within MDHR/DHR ‘s for notification to appropriate value stream.
Achieve a classification of Independent or higher on all Quality Specialist competencies identified on the Quality Specialist Competency Checklist.
Employees must be able to relate to other people beyond receiving instructions. Can get along with co-workers or peers and respond appropriately to feedback from a supervisor in a professional manner.
Aid inspectors with Quality administrative duties when necessary.
Training of individuals on the requirements of customer Quality Shipping paperwork.
Training of individuals on the requirements and completion of MDHR/DHR.
Training of individuals on the requirements of FAI.
Good housekeeping, safe work ethics, and conducting self in a professional manner.
Proper handling of all materials, parts, and equipment to prevent damage and loss of finished product.
Represent the company as required during customer, internal and ISO audits, as well as FDA inspections.
Understand the sensitivity of the data handled by the systems under your control and take appropriate measures to protect it.