Quality Manager

Quality Assurance ManagerInjectech, 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!Location: On-site in Fort Collins, COEssential Duties & Responsibilities:Maintain and continuously improve the electronic Quality Management System (eQMS), quality documentation, and controlled records in accordance with ISO 13485.Ensure compliance with ISO 13485 standards, company Quality Management System (QMS) requirements, Good Documentation Practices (GDP), and applicable regulatory requirements.Establish, maintain, and improve quality procedures, standards, specifications, and documentation systems to support organizational objectives.Coordinate internal audits, external audits, customer audits, and ISO certification activities, including the development and implementation of corrective actions resulting from audit findings.Serve as the primary quality representative for customer quality matters, including quality concerns, corrective actions, compliant investigations, and continuous improvement opportunities.Review customer quality requirements and ensure organizational processes, products, and documentation meet applicable expectations and specifications.Coordinate supplier quality activities and collaborate with the Logistics Manager to establish, communicate, and maintain quality requirements for external suppliers.Oversee calibration programs and coordinate the calibration and certification of inspection equipment, measuring instruments, and related assets.Support and maintain validation and risk management activities, including IQ, OQ, PQ, Verification and Validation (V&V), Failure Mode and Effects Analysis (FMEA), and other quality system requirements.Lead investigations related to nonconforming products, customer complaints, quality events, and Return Material Authorizations (RMAs), ensuring appropriate root cause analysis and corrective actions are implemented.Monitor, analyze, and report quality performance metrics, audit results, customer feedback, and operational trends to support data-driven decision-making and continuous improvement initiatives.Develop and implement quality improvement initiatives focused on waste reduction, process effectiveness, throughput improvement, product quality, and operational efficiency.Support the development and implementation of inspection methods, quality controls, and acceptance criteria for molded and assembled products.Provide guidance and training on quality systems, quality tools, risk management principles, and regulatory requirements to support organizational compliance and continuous improvement.Ensure all assigned quality activities are performed in accordance with established procedures, specifications, and applicable requirements.Perform other duties as assigned.Manager Responsibilities:Lead, coach, and develop team members by providing direction, support, training, feedback, and opportunities for professional growth.Partner with Human Resources in recruitment, interviewing, onboarding, performance management, employee relations, and other personnel-related activities.Establish departmental goals, objectives, and priorities that align with Injectech's mission, strategic initiatives, and business objectives.Plan, organize, and allocate departmental resources, including personnel, budgets, equipment, and time, to support operational effectiveness and achieve department goals.Make informed business decisions by evaluating risks, opportunities, resource requirements, and organizational impact.Conduct performance evaluations, establish employee development goals, provide ongoing coaching and feedback, and support decisions related to promotions, compensation, recognition, and corrective action.Foster a positive, professional, and collaborative work environment that promotes employee engagement, accountability, teamwork, and continuous improvement.Address employee concerns and workplace conflicts in a timely and professional manner to maintain productive working relationships.Collaborate with cross-functional departments to ensure alignment of departmental objectives with broader organizational goals and customer requirements.Identify departmental risks and develop strategies to mitigate potential impacts to safety, quality, delivery, compliance, and operational performance.Ensure compliance with company policies, regulatory requirements, safety standards, and applicable quality system requirements.Promote and maintain safe, organized, and efficient work environments through adherence to company safety programs and 6S Lean principles.Monitor departmental performance through key metrics, operational data, and business objectives, implementing corrective actions and improvement initiatives as needed.Ensure products, services, and departmental activities meet established quality standards, operational requirements, and customer expectations.Support organizational change initiatives, continuous improvement efforts, and strategic business objectives.Prepare departmental updates, metrics, and presentation materials for company meetings and leadership reviews, including participation in quarterly All-Hands presentations.Attend and actively participate in management meetings, training programs, and other business-related functions as required.Qualifications & Skills:Bachelor's degree in Engineering, Quality, Manufacturing, Industrial Technology, or related field; equivalent experience may be considered.Minimum of 5-7 years of experience in quality, compliance, or quality systems management within an ISO-regulated manufacturing environment.Experience within highly regulated industries, such as medical device, automotive, aerospace, or similar regulated manufacturing environments.Minimum of 3 years of leadership or management experience required.Minimum of 3 years of experience working in controlled manufacturing environments, including cleanroom operations.Thorough understanding of ISO 13485 Quality Management Systems (QMS), regulatory compliance requirements, and Good Documentation Practices (GDP).Experience managing electronic Quality Management Systems (eQMS), enterprise resource planning (ERP) systems, databases, and controlled documentation systems.Strong knowledge of quality assurance, quality control, auditing, risk management, validation, corrective and preventative action (CAPA), and continuous improvement methodologies.Knowledge of technical drawings, specifications, manufacturing documentation, and quality requirements related to precision manufacturing processes.Strong proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, and related business software.Six Sigma Green Belt certification or equivalent continuous improvement training preferred; Six Sigma Black Belt certification is a plus.Certified Quality Manager (CQM) certification preferred.Certified Quality Auditor (CQA) certification preferred.Strong organizational, analytical, and problem-solving skills with high attention to detail.Ability to manage multiple priorities, meet deadlines, and work independently while supporting organizational objectives.Strong verbal, written, and interpersonal communication skills, with the ability to collaborate effectively across departments, suppliers, customers, and regulatory bodies.Demonstrated leadership, employee development, coaching, and team-building skills.Proficiency in basic mathematical calculations, measurements, statistical analysis, and data interpretation.Demonstrated commitment to continuous improvement, operational excellence, regulatory compliance, and product quality.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.