Quality Manager

Location

On-site in Fort Collins, CO

This position will remain open until filled.

• 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.

• 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…