Quality Technician 3

Quality Technician 3

Position Summary: 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.

Principal Responsibilities:

• Customer Notification of Change (CNOC) Support
• 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
• Receiving Inspection
• 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
• Document Control
• 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

Education / Experience Requirements:

• Minimum: High school diploma or equivalent, 24 years of experience in a quality or manufacturing role, at least 12 years in a regulated environment (medical device preferred, ISO 13485 or similar such as ISO 9001/FDA 21 CFR 820)
• Preferred: Direct experience with: incoming/receiving inspection, document control systems (paper or eQMS), change control / CNOC or similar customer notification processes

Specialized Skills / Other Requirements:

• 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)

The pay range for this position at commencement of employment is expected to be between $54,200.00 - $81,300.00 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental, and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered.