Job Summary
We are seeking a dedicated and detail-oriented Quality Assurance Technician to join our manufacturing team. In this role, you will be responsible for ensuring that products meet stringent quality standards and comply with industry regulations. Your expertise will support continuous improvement initiatives, uphold quality systems, and maintain compliance with regulatory requirements such as ISO 13485, FDA regulations, and ISO 9001. The ideal candidate will possess strong analysis skills, proficiency with precision measuring instruments, and experience in quality control processes to ensure the delivery of safe, reliable, and high-quality products.
Duties
- Conduct comprehensive quality inspections using precision measuring instruments such as calipers, micrometers, and vision inspection systems to verify product dimensions and specifications.
- Perform quality audits across manufacturing processes to ensure adherence to ISO 13485, CGMP (Current Good Manufacturing Practice), HACCP (Hazard Analysis Critical Control Point), and other regulatory standards.
- Utilize data collection tools and analysis skills to identify trends, root causes of defects, and areas for process improvement.
- Operate coordinate measuring machines (CMM) for detailed dimensional analysis of complex components.
- Maintain accurate documentation of inspection results, non-conformance reports, and corrective actions in compliance with ISO 9001 standards.
- Support calibration and maintenance of quality measurement tools to ensure ongoing accuracy.
- Participate in internal and external quality audits to verify compliance with FDA regulations and industry standards.
- Assist in the development, implementation, and review of quality management systems (QMS) to enhance product quality and process efficiency.
- Collaborate with manufacturing teams to resolve quality issues promptly while promoting a culture of continuous improvement.
- Contribute to training initiatives related to quality assurance procedures and proper use of measurement instruments.
Experience
- Proven experience as a Quality Assurance Technician within a manufacturing environment, preferably in medical device or pharmaceutical sectors.
- Hands-on experience with calibration and operation of precision measuring instruments such as calipers, micrometers, vision inspection systems, and CMMs.
- Familiarity with industry standards including ISO 13485, ISO 9001, FDA regulations, HACCP principles, and CGMP guidelines.
- Strong understanding of quality control processes including inspections, data collection, analysis techniques, and root cause analysis.
- Experience conducting quality audits and supporting compliance efforts within regulated environments.
- Knowledge of QA/QC software tools and statistical analysis methods is advantageous.
- Excellent attention to detail combined with strong analytical skills necessary for thorough product evaluation.
- Effective communication skills for documenting findings clearly and collaborating across departments. This position offers an opportunity to play an integral role in maintaining the highest standards of product quality while supporting regulatory compliance. We welcome candidates committed to excellence in quality assurance practices who are eager to contribute to our mission of delivering safe and reliable products worldwide.
potential shift hours
10am-6:30pm
1pm -9:30pm
Pay: $20.00 - $21.00 per hour
Work Location: In person
