Quality Assurance Manager

Join to apply for the Quality Assurance Manager role at Tissue Source, LLC 3 days ago Be among the first 25 applicants Join to apply for the Quality Assurance Manager role at Tissue Source, LLC This range is provided by Tissue Source, LLC. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $55,000.00/yr - $85,000.00/yr Quality Assurance Manager Location: Frankfort, IN | Type: Full-Time, Salaried | Reports to: CEO/President About Tissue Source Tissue Source, LLC is a trusted supplier of porcine tissue used in medical devices, biologics, research, and biotech industries. Since 2007, we’ve been dedicated to delivering high-quality, compliant products that help advance scientific research and improve global healthcare outcomes. The Role Tissue Source seeks an experienced Quality Assurance Manager to lead and maintain our Quality Management System (QMS) in compliance with FDA regulations, ISO 13485, and client requirements. As part of a small but growing business, this role offers a rare opportunity to apply your quality expertise to help shape our direction and support our growth—while still engaging in hands-on work. You’ll also travel weekly to our offsite abattoir to oversee tissue collection, ensuring quality, traceability, and regulatory compliance throughout the supply chain. Key Responsibilities Manage and continuously improve all aspects of the QMS, including SOPs, risk management, change controls, CAPA, and supplier qualifications. Lead internal and external audits, training programs, and customer feedback management. Support tissue collections to ensure compliance with client specifications and approve product release. Conduct training, quality metrics tracking, and management reviews. Spearhead strategic quality initiatives that adapt to evolving business needs and drive organizational growth Who You Are Experienced in Quality Assurance/Quality Control within regulated industries (medical device experience preferred). Comfortable working hands-on with pig tissues and organs, with the ability to travel once a week to the offsite abattoir. Strong communicator with excellent organizational and analytical skills. Self-motivated and able to work independently in a fast-paced environment. Proficient in Microsoft Office and familiar with quality management software. What will set you apart: Bachelor’s in Science, Biology, Management, or related field Experience with ISO 13485 and FDA-regulated systems Familiarity with animal-derived biological materials and shipping regulations Why Join Us? At Tissue Source, we live by our core values: Quality, Innovation, Integrity, Customer Service, Consultative Collaboration, Commitment, and Success. You’ll join a team dedicated to making a meaningful impact on medical research and patient care worldwide. If you’re passionate about quality and ready to make a difference, we want to hear from you! Must be legally authorized to work in the U.S. without employer sponsorship (now or in the future) Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Quality Assurance Industries Medical Equipment Manufacturing, Health and Human Services, and Food and Beverage Services Referrals increase your chances of interviewing at Tissue Source, LLC by 2x Get notified about new Quality Assurance Manager jobs in Frankfort, IN . Lead Continuous Improvement Engineer (Warehousing) Whitestown, IN $100,000.00-$110,000.00 3 days ago Production Superintendent – Cut Floor - 2nd shift We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr