Medical Device Quality Control Technician Harba Solutions - 1.0 Fishers, IN Job Details Full-time $25 - $30 an hour 10 hours ago Qualifications Measurement-based inspection Machine vision systems ISO standards GMP Shop math Mechanical drawings Dimensional measurements Continuous improvement Attention to detail Precision measurement in machining Regulatory/legal compliance standards in production Biomedical regulatory compliance Quality audits Mechanical knowledge FDA regulations Full Job Description Overview Join our dynamic team as a Medical Device Quality Control Technician and play a vital role in ensuring the safety, reliability, and compliance of our innovative medical devices. In this energetic position, you will be responsible for performing precise inspections, measurements, and quality assessments to uphold the highest standards in manufacturing. Your expertise will help maintain regulatory compliance, support quality assurance initiatives, and contribute to delivering life-saving products to patients worldwide. This role offers an exciting opportunity to work at the forefront of medical technology with a focus on precision, compliance, and continuous improvement. Duties Conduct dimensional and visual inspections of medical device components using precision measuring instruments such as height gauges, coordinate measuring machines (CMM), and vision inspection systems. Interpret mechanical blueprints, manufacturing documents, and technical specifications to verify product conformity with quality standards. Perform quality audits and data collection to monitor adherence to

ISO 13485, ISO 9001, GMP

(Good Manufacturing Practices), and FDA regulations. Utilize calibration procedures for measuring instruments and ensure all tools meet calibration standards for accuracy. Support manufacturing teams by identifying non-conformances through detailed analysis skills and implementing corrective actions aligned with quality management systems. Assist in maintaining compliance with regulatory/legal standards in production by documenting inspection results and preparing reports for quality assurance review. Participate in root cause analysis for quality issues, contributing to continuous improvement initiatives within the production environment. Requirements Proven experience in quality control or quality assurance within manufacturing environments, preferably in the medical device industry. Strong mechanical knowledge with the ability to interpret mechanical blueprints and GD&T (Geometric Dimensioning & Tolerancing). Familiarity with ISO standards such as

ISO 13485

(medical devices), ISO 9001 (quality management), and GMP regulations including FDA requirements. Proficiency with measurement tools including height gauges, coordinate measuring machines (CMM), vision inspection systems, and other precision measuring instruments. Knowledge of quality systems, audits, data collection methods, and regulatory compliance standards related to medical device manufacturing. Basic math skills essential for dimensional measurements and analysis; experience with calibration procedures is a plus. Ability to interpret production documents accurately while adhering to strict quality standards in production processes. Mechanical aptitude combined with attention to detail ensures precise inspections and measurements are consistently achieved. Embark on a career where your skills directly impact patient safety and product excellence! We are committed to fostering an inclusive environment that values innovation, precision, and continuous learning—making every day an opportunity to grow professionally while contributing to meaningful healthcare solutions.

Pay:

$25.00 - $30.00 per hour

Work Location:

In person