Quality Engineer

Quality EngineerInjectech, 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, COEssential Duties & Responsibilities:Own and maintain the organization's metrology and calibration systems, ensuring measurement accuracy, traceability, and compliance with ISO 13485 requirements.Develop, implement, and continuously improve calibration programs, including calibration intervals, asset tracking, documentation, and coordination of external calibration service providers.Plan, execute, and evaluate Measurement System Analysis (MSA) activities, including Gauge R&R, bias, linearity, and stability studies to ensure measurement system capability.Develop and maintain inspection plans, inspection methods, sampling strategies, and quality control techniques to support manufacturing and inspection processes.Perform statistical analyses, including Statistical Process Control (SPC), capability studies, Design of Experiments (DOE), and trend analysis to support process improvement and product quality objectives.Support product and process validation activities by ensuring measurement systems are validated, capable, and appropriate for intended use.Lead and support investigations related to measurement system performance, nonconforming, products, and quality issues through root cause analysis, corrective actions, and preventative actions (CAPA).Coordinate and participate in Material Review Board (MRB) activities to evaluate nonconforming materials, determine product disposition, and support associated corrective actions.Monitor, analyze, and report calibration performance metrics, measurement system effectiveness, inspection data, product returns, and quality trends to support continuous improvement initiatives.Serve as a Quality Engineering liaison for internal and external customers, supporting quality-related activities, PPAP documentation, and cross-functional quality improvement efforts.Maintain quality records, controlled documents, and supporting documentation within applicable quality management systems to ensure compliance with internal procedures and regulatory requirements.Lead and support risk management activities in accordance with ISO 13485 and applicable regulatory requirements.Ensure compliance with ISO 13485 standards, company Quality Management System (QMS) requirements, and applicable regulatory expectations.Support the onboarding, training, and development of interns and other team members by providing guidance on quality systems, metrology practices, inspection methods, and engineering best practices.Perform other duties as assigned.Qualifications & Skills:Bachelor's degree in engineering or related field; equivalent experience may be considered.Minimum of 3-5 years of manufacturing experience, preferably in injection molding or ISO-regulated manufacturing environments.Six Sigma Green Belt certification or equivalent continuous improvement training preferred; Six Sigma Black Belt certification is a plus.Strong knowledge of quality engineering principles, including statistical analysis (MSA), and process control methodologies.Experience utilizing statistical tools and quality methodologies, including Statistical Process Control (SPC), Design of Experiments (DOE), capability analysis, and root cause analysis.Ability to interpret technical drawings, specifications, and Geometric Dimensioning and Tolerancing (GD&T) requirements.Experience working with metrology systems, calibration management systems, and inspection equipment to ensure measurement accuracy and compliance.Experience working within ISO-regulated Quality Management Systems (QMS) and regulated manufacturing environments preferred.Knowledge of quality assurance practices, product validation, risk assessment, and regulatory compliance requirements.Strong organizational, analytical, and problem-solving skills with high attention to detail.Ability to manage multiple priorities, meet deadlines, and work independently with minimal supervision.Strong verbal, written, and interpersonal communication skills, with the ability to collaborate effectively across departments.Proficiency in basic mathematical calculations, statistical analysis, measurements, and data interpretation.Demonstrated commitment to continuous improvement, product quality, process performance, and operational excellence.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, reviewing technical documentation, performing inspections, and working with detailed components and measurement equipment.Physical agility to bend, kneel, reach, and perform hands-on inspection, measurement and quality verification activities.Precise hand-eye coordination for handling measuring instruments, inspection equipment, small components, and documentation accurately.Ability to lift and/or move up to 60 lbs., with or without reasonable accommodation.Comfortable working in manufacturing environments with varying temperatures, noise levels, and exposure to industrial materials.Benefits401(K) Retirement PlanProfit Share ProgramMedical, Dental, Vision, Life & AD&D Insurance, Short Term Disability (STD), Long Term Disability (LTD), Supplemental Insurance Plans, and Employee Assistance Program (EAP)Sick Time, Vacation Time, Holiday Pay, Volunteer Time Off (VTO), and BereavementDrug Testing PolicyInjectech 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.