Quality Assurance Specialist
tmCMF is a high-tech, medical device company dedicated to creating, innovating, and developing software and hardware technology solutions for plastic, orthopedic, and neurosurgeons for improved surgical planning and patient outcomes. Determined to shape the future of healthcare, tmCMF’s intuitive, surgeon-driven digital application unites patient-focused healthcare and artificial intelligence to deliver customized 3D printed implants and trauma plates to global surgeons and patients.
The Quality Assurance Specialist is critical in supporting the implementation, maintenance, and performance of the Quality Management System. This position will support the alignment of company policies and processes to applicable standards and help promote awareness of regulatory and quality management system requirements throughout the organization. The QA Specialist will participate in all aspects of the QA job function including participation in product life cycle development from concept to commercialization. The QA Specialist must be highly motivated, dynamic, and comfortable working in a fast-paced, small, but sharp tech team. This position will require someone to be a self-starter, and someone who is always eager to help, and is comfortable wearing multiple hats. Work is generally independent and collaborative in nature. This position will report directly to the Vice President of Quality Assurance.
What you will be doing
- Facilitate in the management of the company’s Quality System
- Ensure that the Quality System is and remains in compliance with applicable State statues, Federal regulations, and other laws, including Title 21 CFR 820 Regulations
- Champion quality and compliance of policies and procedures that drive quality responsibility throughout the organization
- Collaborate with team members to create new and modify existing QA procedures and other related forms and instructions as needed
- Assist and support investigations of nonconforming product, customer complaints, and corrective and preventive actions
- Support internal audit program; audit systems and documents to assure quality assurance compliance to all internal procedures and regulatory guidelines; audit vendors as needed
- Maintain and demonstrate understanding of global standards, regulation, and regulatory bodies to include but not limited to ISO 13485, ISO 14971, FDA QSR
- Support continual improvement activities
- Perform other duties as assigned
What you will bring along
- Minimum 3+ years Quality Assurance-related professional experience
- Medical Device-related industry experience preferred
- Working knowledge of ISO 13485 and 21 CFR 820 desired
- Bachelor’s Degree from an accredited college in a related discipline
- Ability to function well as a member of the team, interface and communicate effectively with employees, management, customers, and regulatory agencies, as well as build relationships across areas of the organization
- Ability to manage competing priorities; ability to manage projects of various sizes, conditions, and management of personnel; versatility, flexibility, and willingness to work with changing priorities
Culture & Benefits
tmCMF is an innovation powerhouse with a passion for people. Whether you are looking to grow an existing career or you’re just out of college, we are interested in what you can do, not your age. Prepare to be challenged, supported, and inspired by a talented group of founding leaders with demonstrated achievements in the field. Help us create a culture where everyone is included and is encouraged to be their best.
What we promise
- Competitive pay with milestone-based incentives
- Industry-leading Medical, Dental, and Vision coverage
- Hybrid work environment with the ability to craft your calendar and create important work/life balance
- Four weeks of paid time off annually
- 401(K) with 4% company match
- Continuing education/Training Assistance/Mentoring
Our Headquarters
Knoxville, Tennessee is a rapidly growing city featuring a sophisticated culture and unique mountain charm. Home to several parks and greenways within the city limits and only a short drive from the Great Smoky Mountains National Park, there’s no shortage of trails to explore.
In the heart of the city, you can enjoy live music in Market Square or indulge in a collection of microbreweries and local eateries throughout the Old City — a revitalized historic neighborhood featuring trendy local businesses and makers.
With no state income tax and a low cost of living in a cultured city, there’s something for everyone to love in Knoxville. Out of 125 US cities, Knoxville was ranked #46 “Best Places to Live in the USA” by U.S. News & World Report.
We are always looking for talented individuals to join our team. If you’re interested in applying for a position with tmCMF, please submit your resume to [email protected].