Quality Assurance Specialist

Summary: WalkMed Infusion is a small, fast-moving medical device company located in the Denver area. They are seeking a Quality Assurance Specialist who will be responsible for ensuring compliance with quality standards, conducting quality control checks, performing audits, and managing processes to maintain high-quality output. Responsibilities: - Manage the Complaint Handling Process, including Medical Device Reports when required - Support Corrective and Preventive Actions (CAPAs) - Assist with vendor qualification, monitoring, and supplier management - Maintain and update quality and regulatory documentation - Help prepare regulatory submissions and responses - Participate in internal and external audits - Track and follow up on quality metrics and improvement efforts - Collaborate with Operations and Engineering teams - Ensure accuracy and completeness of quality records - Support overall Quality System Compliance Required Qualifications: - Bachelor's degree in a scientific, engineering, or healthcare field - OR equivalent experience in medical device RA/QA (1–3 years preferred) - Knowledge of ISO 13485, FDA 21 CFR Part 820, and regulated environments - Strong organization, communication, and technical writing skills - Proficiency with Microsoft Office (Outlook, Word, Excel) - Self-starter with excellent attention to detail Preferred Qualifications: - Medical terminology - Working with databases - GDP, GMP, and quality system practices Required Skills: ISO 13485, FDA 21 CFR Part 820, Quality Management System Important Skills: Microsoft Office Nice-to-Have Skills: Medical terminology, Working with databases, GMP, Quality system practices, Technical writing, Communication skills, Attention to detail Benefits: Health insurance, Retirement plan options, Paid time off