Quality Assurance Manager

Job Summary
We are seeking a dynamic and detail-oriented Quality Assurance Manager to lead our quality management initiatives across manufacturing and production processes. In this pivotal role, you will oversee the development, implementation, and continuous improvement of quality systems to ensure compliance with industry standards and regulatory requirements. Your expertise will drive excellence in quality control, inspection, and assurance, fostering a culture of quality that supports our commitment to delivering safe, reliable products to our customers. This position offers an exciting opportunity to influence product integrity and operational efficiency on a global scale.

Duties

• Develop, implement, and maintain comprehensive quality management systems aligned with ISO 13485, ISO 9001, and other relevant standards.
• Lead internal and external quality audits to verify compliance with FDA regulations, HACCP protocols, CGMP guidelines, and other regulatory frameworks.
• Oversee quality control processes including inspections, testing, and validation activities throughout manufacturing operations.
• Coordinate root cause analysis for quality issues and implement corrective and preventive actions (CAPA) to resolve non-conformities effectively.
• Manage documentation related to quality assurance activities, audit reports, compliance records, and process improvements.
• Collaborate with cross-functional teams such as manufacturing, engineering, and regulatory affairs to ensure product safety and quality standards are met consistently.
• Drive continuous improvement initiatives by analyzing data trends, conducting risk assessments, and refining quality systems to enhance efficiency and compliance.

Requirements

• Proven experience in quality assurance or quality management within manufacturing environments, preferably in regulated industries such as medical devices or pharmaceuticals.
• Russian — required (Russian-speaking).
• 5+ years of experience in Quality Assurance (required).
• Strong knowledge of ISO medical device quality management), FDA regulations (21 CFR Part 820), HACCP principles, CGMP standards, and ISO 9001 standards.
• Full-time, on-site position in Commerce City, CO
• Demonstrated expertise in conducting quality audits and inspections across complex production processes.
• Excellent analysis skills with the ability to interpret data, identify issues, and develop strategic solutions.
• Project management skills to lead initiatives from planning through execution while maintaining compliance deadlines.
• Exceptional communication skills for training teams, preparing reports, and liaising with regulatory bodies.
• Relevant certifications such as CQE (Certified Quality Engineer), Lead Auditor credentials or equivalent are highly desirable. Join us as we uphold the highest standards of quality excellence Your leadership will ensure our products meet rigorous safety requirements while fostering innovation through continuous improvement. If you're passionate about elevating quality systems and making a tangible impact on product integrity worldwide—this is your moment

Job Type: Full-time

Pay: $60, $80,000.00 per year

Benefits:

• Employee discount
• Flexible spending