About Job

The Quality Metrology Technician is responsible for supporting quality assurance and metrology functions to ensure that products meet internal and customer specifications. This role involves analyzing processes, identifying root causes of defects, recommending improvements, and supporting validation and inspection activities. The technician works closely with engineering, production, and quality teams to drive continuous improvement and maintain compliance with regulatory standards.

Key Accountabilities:

Adhere to all company policies and serve as a role model in policy interpretation and customer service.

Provide training support on:

ISO 13485 requirements
FDA CFR 820 regulations
Micron Quality System requirements
Auditing and Statistical Process Control (SPC)

Program, set up and operate inspection/metrology equipment, including CMMs and optical/mechanical tools.

Establish measurement methodologies for plastics or metals substrate.

Schedule and manage measurement activities (i.e Gage R&R and Bias studies)

Support manufacturing, product development, and project teams with metrology input and recommendations.

Work with internal and external customers to verify product specifications and define acceptable variate levels.

Develop and analyze production and statistical data to ensure processes meet quality expectations and identify improvement opportunities.

Ability to work within a statistical sampling plan (i.e. ANSIZ1.4)

Assist in developing measurement qualifications to be used with validation plans for products

Education & Experience

Bachelor’s degree in engineering or related field, or a minimum of 5 years in a Metrologist role
Medical device manufacturing experience preferred

Certifications (Preferred)

ASQ Certified Calibration Technician

Technical Skills

Strong understanding of metrology and statistical analysis.
Working knowledge of plastics injection molding and metal manufacturing
Proficient in CMM operation and programming (minimum 3-5 years with Hexagon PC-DMIS).
Skilled in using optical and mechanical measurement tools.
Experience with ERP systems (IQMS preferred).
Familiarity with ISO 13485 and FDA CFR 820 regulations.
Proficient in Microsoft Office Suite and Mini Tab

Other Skills

Strong organizational, communication, and facilitation skills.
Ability to work independently in a fast-paced, dynamic manufacturing environment.
Experience with validation protocols

PM21