Quality Technician

Injectech; Fort Collins (CO); On-site; USD 52,000 - 68,000; Full time

Benefits offered by this job

401(K) Retirement Plan

Medical, Dental, Vision, Life & AD&D

Sick Time & Vacation

Holiday Pay

Volunteer Time Off

Employee Assistance Program (EAP)

Job summary

Injectech, a longtime medical device supplier, is seeking a Quality Inspector to perform rigorous inspections of materials, components, and finished products. You will document data per GDP and QMS, review drawings, and help identify nonconforming items and corrective actions.

Experience in cleanroom environments and ISO 13485 familiarity are highly valued. The role is on-site in Fort Collins, CO with a Sun-Thurs schedule.

Qualifications

• High school diploma or equivalent required; technical training or related education preferred.
• Previous experience in quality inspection or manufacturing, especially medical devices, is preferred.
• Cleanroom gowning and training may be required, with willingness to complete them.

Responsibilities

• Inspect incoming materials, in-process components, and finished products per specs and procedures.
• Record and analyze inspection data following GDP and QMS requirements.
• Review documentation to verify conformance to requirements.
• Identify nonconforming materials and communicate corrective actions.
• Support investigations into quality issues and customer concerns.
• Maintain quality records and support continual improvement initiatives.

Skills

Attention to detail

English communication

Team coordination

Education

High school diploma or equivalent

Technical training preferred

Tools

Calibrated measuring equipment

eQMS / ERP software

Microsoft Office

Job description

Injectech, LLC has been a trusted supplier of fluid-control components for over 20 years. Our current senior management team has been with Injectech since the very beginning, bringing extensive knowledge of the medical device industry to every project.

Our employees are important to us! We want the best for our employees, not just at work, but through all aspects of their life. That is why we offer comprehensive benefits including health insurance, a 401(k) plan with up to 6% company match, and access to free financial advice about retirement, debt, and any future financial needs from a licensed Financial Advisor. We strongly believe that the only way for our company to be successful is to make sure our employees have healthcare, mental healthcare, retirement options and financial education available to them.

We work hard to create a culture that promotes open lines of communication, a flexible work-life balance, continuous improvement in every department, and a place where employees want to be every day. We strive to hire and retain the best people, because we know a company is only as good as its employees. We hope you will join our team as we continue to grow and improve!

This position will remain open until filled.

Location:On-site in Fort Collins, CO

Schedule & Hours:Sun-Thurs, 6:30am-3:00pm

Essential Duties & Responsibilities:

• Perform inspection and testing of incoming materials, in-process components, and finished products according to established specifications, procedures, and work instructions.
• Collect, record, and analyze inspection and test data accurately and in accordance with Good Documentation Practices (GDP).
• Review product and process documentation to verify compliance with established requirements.
• Identify, document, and communicate nonconforming materials, components, or products in accordance with established procedures.
• Support the evaluation and disposition of nonconforming product, including appropriate containment and corrective actions.
• Perform quality inspections using calibrated measuring equipment and other applicable inspection tools.
• Read and interpret technical drawings, specifications, and work instructions to perform inspections and determine product conformity.
• Verify that materials and products meet applicable requirements prior to release, as authorized by established procedures.
• Support investigations into quality issues, customer concerns, and production-related quality problems.
• Assist with continuous improvement activities and recommend opportunities to improve product quality, inspection methods, and manufacturing processes.
• Maintain accurate and complete quality records in accordance with company procedures and the Quality Management System (QMS).
• Follow applicable ISO 13485, QMS, safety, cleanroom, and company requirements.
• Maintain a clean, orderly, and safe work area and follow applicable cleanroom gowning and environmental requirements.
• Participate in internal audits, quality projects, training, and other quality-related activities as assigned.
• Maintain current knowledge of applicable quality requirements, inspection methods, and industry practices through training and other professional development activities.
• Perform other duties as assigned.

Qualifications & Skills:

• High school diploma or equivalent required; technical training, certificate, or related education preferred.
• Previous experience in quality inspection, manufacturing, medical device manufacturing, or another regulated manufacturing environment preferred.
• Experience working in a cleanroom environment preferred; willingness and ability to complete required cleanroom gowning and training required.
• Working knowledge of ISO 13485 and quality management system principles preferred.
• Working knowledge of Good Documentation Practices (GDP) and controlled documentation.
• Experience using calibrated measuring and inspection equipment preferred.
• Ability to read and interpret technical drawings, specifications, and work instructions.
• Basic understanding of quality control methods, inspection techniques, and statistical concepts.
• Familiarity with electronic Quality Management Systems (eQMS), ERP systems, and other quality or manufacturing software preferred.
• Proficiency with Microsoft Office applications (Excel, Word, etc.)
• Strong attention to detail and organizational skills.
• Strong written, verbal, and interpersonal communication skills in English.
• Ability to manage multiple priorities and deadlines with limited supervision.
• Ability to perform basic mathematical calculations, including addition, subtraction, multiplication, division, measurements, and decimals.
• Ability to work effectively both independently and as part of a team.
• Demonstrated commitment to quality, safety, efficiency, and continuous improvement.

Work Environment & Physical Demands:

• Ability to sit, stand, and walk for extended periods throughout the workday (up to 8 hours).
• Ability to communicate verbally, hear clearly, and maintain corrected vision sufficient for reading, writing, inspecting components, and completing required documentation.
• Physical agility to bend, kneel, reach, and work in various positions while performing repetitive and detail-oriented tasks.
• Ability to lift and/or move up to 50 lbs., with or without reasonable accommodation.
• Requires manual dexterity and hand-eye coordination for handling small components, inspection equipment, tools, and other materials.
• Comfortable working in manufacturing environments with varying temperatures, noise levels, and exposure to industrial materials.
• Comfortable working in cleanroom environments,following all applicable cleanroom gowning, hygiene, PPE, safety, and contamination-control requirements.
  

Benefits

• 401(K) Retirement Plan

• Medical, Dental, Vision, Life & AD&D Insurance, Short Term Disability (STD), Long Term Disability (LTD), Supplemental Insurance Plans, andEmployee Assistance Program (EAP)

• Sick Time, Vacation Time, Holiday Pay, Volunteer Time Off (VTO), and Bereavement

Drug Testing Policy

Injectech is committed to maintaining a safe and productive workplace. As part of this commitment, all potential employees must pass a drug screening as a condition of employment. The drug test is a 5-panel screening and must be completed to your start date.

Injectech is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law. We are committed to creating a diverse and inclusive workplace and encourage candidates from all backgrounds to apply.