Quality Technician

We are seeking a detail-oriented Quality Inspector to support the inspection of precision‑manufactured components, subassemblies, and finished products in a regulated medical device manufacturing environment. This role is responsible for performing in‑process and final inspections to ensure products meet established quality standards before advancing through production or release. The ideal candidate is experienced working within a Quality Management System (QMS) and thrives in a highly regulated manufacturing environment. Responsibilities Perform visual, dimensional, and functional inspections of precision components, subassemblies, and finished medical devices using calibrated inspection equipment, optical comparators, microscopes, and other metrology tools. Conduct final product inspections and support product release activities in accordance with approved quality procedures. Inspect mechanical assemblies and device subcomponents at designated manufacturing checkpoints. Complete inspection documentation, Device History Records (DHR), and nonconformance reports (NCRs) accurately and in a timely manner. Identify, segregate, document, and process nonconforming materials in accordance with established quality procedures. Initiate and support NCR investigations by providing objective inspection data and documentation. Assist with root cause investigations and Corrective and Preventive Action (CAPA) activities by supplying inspection findings and trend information. Maintain complete, accurate, and compliant inspection records following Good Documentation Practices (GDP). Assist in developing and revising inspection procedures, work instructions, acceptance criteria, and inspection plans in collaboration with Manufacturing and Quality Engineering teams. Verify all inspection equipment is within calibration prior to use. Identify out‑of‑calibration equipment and initiate calibration requests in accordance with company procedures. Maintain proper care and handling of inspection equipment used in regulated manufacturing. Qualifications 3–5 years of quality inspection experience within a regulated medical device manufacturing environment. Experience inspecting complex, precision‑assembled products is required. Experience with implantable, sterile, or other highly regulated medical devices is preferred. Experience inspecting delicate assemblies, textiles, soft materials, or other precision components is highly desirable. Previous experience supporting a growing or early‑stage manufacturing organization is a plus. ASQ Certified Quality Inspector (CQI) or Certified Quality Technician (CQT) preferred. ASQ Certified Quality Auditor (CQA) is a plus. Working knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, or comparable quality standards. Ability to read and interpret engineering drawings and apply GD&T principles. Familiarity with nonconformance reporting, CAPA processes, and quality documentation. Knowledge of cleanroom manufacturing practices and contamination control is preferred. Proficiency using precision inspection equipment, including calipers, micrometers, optical inspection systems, and microscopes. Experience working with electronic Quality Management Systems (eQMS) and Microsoft Office; familiarity with systems such as MasterControl, Greenlight Guru, or similar platforms is a plus. Strong written and verbal communication skills with the ability to clearly document inspection results. Excellent attention to detail, organizational skills, and the ability to prioritize work in a fast‑paced manufacturing environment. Demonstrated problem‑solving mindset and commitment to continuous improvement. Ability to work independently while collaborating effectively with Manufacturing, Engineering, and Quality teams. Comfortable working in a cleanroom or other controlled manufacturing environment. Compensation: $55,000–$75,000 annually, depending on experience and qualifications. #J-18808-Ljbffr Cypress HCM