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Quality Inspector Picocyl, LLC - 5.0 Golden, CO Job Details Full-time $28 - $30 an hour 4 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Paid time off Employee assistance program Vision insurance 401(k) matching Professional development assistance Life insurance Qualifications Measurement-based inspection ISO standards Good documentation practices (GDP) GMP High school diploma or GED Manufacturing facility experience Dimensional measurements Precision measurement in machining Organizational skills Regulatory/legal compliance standards in production Cleanroom experience Biomedical regulatory compliance Productivity software Manufacturing company experience FDA regulations Full Job Description

POSITION SUMMARY

The Quality Inspecter is a key role within Picocyl's manufacturing facilities using hands-on experience with inspection equipment, and judgment inspecting products and contributing to the overall Quality and Compliance level of Picocyl. In this role, you will ensure adherence to company, regulatory, and customer requirements.

PRIMARY RESPONSIBILITIES

Quality Inspection Perform incoming, in-process, and final inspections of raw materials, components, subassemblies, and finished products. Verify products meet specifications, work instructions, and customer requirements. Conduct visual, dimensional, and functional inspections using approved inspection methods. Approve or reject materials and products based on established acceptance criteria. Testing and Measurement Verify calibration status of inspection and measurement equipment before use. Use measuring and testing equipment such as calipers, micrometers, gauges, comparators, and inspection fixtures; record inspection and test results accurately and completely. Documentation and Recordkeeping Review and approve product labeling. Complete inspection records, batch records, quality forms, and electronic documentation. Maintain accurate records in accordance with company procedures and regulatory requirements. Ensure all documentation is completed in a timely manner. Nonconforming Material Control and CAPAs Identify, document, and segregate nonconforming materials and products. Initiate nonconformance reports and communicate quality issues to appropriate personnel. Participate and support investigations and effectiveness verifications of product quality issues. Regulatory and Compliance Activities Maintain compliance with applicable quality standards, including

ISO 9001, ISO

13485, FDA, GMP, and customer-specific requirements. Support internal, customer, and regulatory audits. Follow all company safety policies and cleanroom requirements, when applicable.

GENERAL RESPONSBILITIES

Communicate quality concerns to production leads, supervisors, technicians and management teams where appropriate. Work closely with manufacturing personnel to resolve quality issues. Participate in cross-functional meetings and continuous improvement initiatives.

REQUIRED QUALIFICATIONS

High school diploma or GED required 5+ years of manufacturing or quality inspection 3+ years of experience performing inspections in a manufacturing environment Knowledge of ISO 13485-2016 and/or 21 CFR 820 Quality Management Systems required. Experienced in Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) principles and their application within a regulated manufacturing environment. Proficiency with precision measuring equipment. Experience with Microsoft Office and electronic quality systems. Strong attention to detail, organizational skills, and problem-solving abilities.

PHYSICAL REQUIREMENTS

Stand and/or walk for extended periods during the workday. Lift and carry materials weighing up to 25-50 pounds. Perform repetitive motions, including bending, reaching, grasping, and handling small components. Work in a manufacturing and/or cleanroom environment, as required by the position. Perform the essential functions of the position, with or without reasonable accommodation. Join us in elevating product quality through meticulous inspection practices! Your dedication will ensure our manufacturing processes produce safe, reliable products that meet or exceed industry standards—making a tangible difference every day.

Pay:

$28.00 - $30.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Health savings account Life insurance Paid time off Professional development assistance Vision insurance

Work Location:

In person