Quality Technician 3

Teleflex•Plymouth, MN

3d•$54,200 - $81,300•Onsite

About The Position

The Quality Technician supports the Quality Management System in compliance with ISO 13485 requirements. This role is responsible for performing receiving inspection, supporting Customer Notification of Change (CNOC) activities for all OEM facilities, and maintaining document control to ensure product quality, traceability, and regulatory compliance in medical device manufacturing.

Requirements

High school diploma or equivalent
2–4 years of experience in a quality or manufacturing role
At least 1–2 years in a regulated environment (medical device preferred, ISO 13485 or similar such as ISO 9001/FDA 21 CFR 820)
Basic understanding of ISO 13485 and change control requirements
Familiarity with document control systems and revision control
Strong attention to detail and accuracy in documentation
Ability to read and interpret technical drawings and specifications
Effective communication and coordination across departments
Basic computer skills (e.g., Microsoft Office, document management software)

Nice To Haves

Direct experience with: Incoming/receiving inspection
Document control systems (paper or eQMS)
Change control / CNOC or similar customer notification processes

Responsibilities

Support the preparation and processing of Customer Notifications of Change for product, process, supplier, or documentation changes
Ensure CNOC documentation is complete, accurate, and aligned with internal change control records
Track CNOC status, including submission, customer acknowledgment, and approval timelines
Maintain records of customer approvals and ensure changes are not implemented prior to required approvals
Coordinate with cross-functional teams (Engineering, Contracts, Operations) to gather required change information
Assist in assessing whether changes require customer notification based on procedures and risk classification
Perform incoming inspection of raw materials and components per approved specifications and sampling plans
Verify Certificates of Conformance (CoC) and supplier documentation for completeness and accuracy
Document inspection results in accordance with Good Documentation Practices (GDP)
Identify, document, and segregate nonconforming materials
Communicate supplier quality issues to Quality Engineering or Supplier Quality
Use standard measurement tools (e.g., calipers, micrometers, optical systems) to verify product conformance
Ensure inspection equipment is within calibration and properly maintained
Maintain accurate, complete, and legible inspection records
Maintain and control quality system documents in accordance with document control procedures
Ensure only current, approved revisions are available at points of use
Process document changes, including formatting, routing for review, and release
Archive obsolete documents per retention requirements
Update training records associated with document revisions
Support periodic document reviews for compliance