Metrology/Programmer - QA Technician III

Job Description

We are seeking a highly skilled Quality Assurance Technician III - Metrology with demonstrated expertise in Coordinate Measuring Machines (CMM) and Industrial CT Scanning to support dimensional inspection and quality assurance activities in a medical plastic injection molding environment. This role serves as a technical authority for advanced measurement technologies, ensuring critical medical device components meet stringent dimensional, regulatory, and customer requirements.

The ideal candidate has deep experience in CMM programming, CT scan data interpretation, GD&T analysis, and process capability, and thrives in a regulated manufacturing environment.

Key Responsibilities

Advanced Metrology & Dimensional Inspection

Perform complex dimensional inspections of medical injection molded components using CMMs and industrial CT scanning systems, as well as other precision measurement tools.

Develop, program, and optimize CMM inspection programs (e.g., PC-DMIS or equivalent).

Execute and analyze CT scan measurements for internal geometry, wall thickness, porosity, and complex features not accessible through traditional measurement methods.

Interpret and apply GD&T (ASME Y14.5) to ensure accurate and repeatable measurement strategies.

Inspection Planning & Measurement Strategy

Lead development of inspection plans, measurement strategies, and sampling methodologies for new and existing products.

Partner with Engineering, Tooling, and Manufacturing during NPI, First Article Inspection (FAI), PPAP, and validation activities to define appropriate measurement approaches using CMM and CT technologies.

Evaluate part design and tooling for measurability and provide feedback to Engineering.

Calibration & Equipment Management

Perform calibration, verification, and routine maintenance of CMM and CT scanning systems, ensuring ongoing accuracy and compliance.

Maintain calibration and verification records in accordance with ISO 13485 and internal Quality Management System (QMS) requirements.

Support measurement system analysis (MSA) for CMM and CT equipment.

Statistical Analysis & Problem Solving

Apply SPC, MSA, and capability studies (Cp/Cpk) to evaluate manufacturing process performance.

Lead root cause investigations related to dimensional nonconformances and measurement system issues using structured problem-solving methodologies.

Drive and support CAPA activities tied to metrology and inspection findings.

Documentation & Regulatory Compliance

Document inspection results, CT scan analyses, deviations, and investigations in compliance with FDA 21 CFR Part 820, ISO 13485, and internal procedures.

Support internal, customer, and regulatory audits related to metrology, CMM, and CT scanning processes.

Training, Mentorship & Technical Leadership

Serve as the site subject matter expert (SME) for CMM and CT scanning technologies.

Train and mentor Quality Technicians and Manufacturing personnel on metrology principles, GD&T, and equipment operation.

Establish and improve standardized work and best practices for advanced metrology.

Continuous Improvement & Cross-Functional Collaboration

Lead continuous improvement initiatives focused on measurement accuracy, efficiency, and automation.

Collaborate with Engineering, Quality, Operations, and Tooling to resolve quality issues and improve process robustness.

Communicate metrology findings clearly and effectively to cross-functional teams and leadership.

Qualifications & Experience

Education

Bachelor's degree in Engineering, Metrology, Quality, or related technical field preferred

Equivalent experience in advanced metrology will be considered

Experience

3-5+ years of experience in metrology or quality roles within medical device manufacturing, plastic injection molding, or other regulated industries

Hands-on experience with CMM programming and industrial CT scanning required

Technical Skills

Proficiency with CMM programming software (PC-DMIS or equivalent)

Experience analyzing CT scan data for dimensional inspection, wall thickness, internal features, and defect detection

Strong knowledge of GD&T (ASME Y14.5)

Working knowledge of SPC, MSA, Cp/Cpk

Familiarity with ISO 13485 and FDA QSR (21 CFR Part 820)

Core Competencies

Exceptional attention to detail and precision

Strong analytical and problem-solving skills

Ability to work independently and as a technical leader

Clear written and verbal communication skills

Collaborative mindset with a continuous improvement focus

Preferred

Experience with Zeiss, Hexagon, Nikon, or similar CT scanning platforms

Experience with vision systems and non-contact metrology

Six Sigma or Quality-related certifications

Full-time