This position will remain open until filled.
Location: On-site in Fort Collins, CO
Essential 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.
Benefits
- 401(K) Retirement Plan
- Profit Share Program
- Medical, 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 Bereavement
