The North Sioux City (NSC) Quality Manager has ultimate, day-to-day responsibility for assuring quality processing in the facility. As NextBeam is in the business of medical device sterilization, our promise of quality is paramount to our customers, and thus our QA Manager plays one of the most critical roles in the company.
As NextBeam’s facility is currently under construction, the QA Manager will have the opportunity to help define how NextBeam’s QA process robustly meets ISO standards and functions on a daily basis. This is a rare opportunity to build and operate a modern, best-in-class, highly efficient quality system from the ground up.
Ideally applicants have experience with ISO 11137-compliant radiation sterilization processes already. If not, demonstrated experience with the scientific method / running scientific processes in a business environment is a must. Familiarity with working in ISO-audited environments and preparing for those audits is also strongly preferred.
Your balance of scientific rigor and entrepreneurial spirit will play a critical role in developing lean and efficient quality and dosimetry processes. Your organizational and quality acumen are then critical to running and continuously improving these processes on a daily basis.
We envision the successful QA Manager to be a player-coach, being able to both operate the QA system solo as well as hire, train, and manage a small team.
As NextBeam’s business grows, there is significant growth opportunity here for the successful QA Manager to increase the scope of their role across multiple sites.
Key Responsibilities / Duties:
Become NextBeam’s subject-matter expert on dosimetry and radiation sterilization concepts. You are (or will become) expert on ISO 11137 and ISO 13485 standards for radiation processing and quality.
Quality audit lead - you will lead the quality aspects of an ISO 13485 audit
Process design and continuous improvement - you will collaborate with the General Manager to own the quality process, initially operate it yourself, and continuously evolve/improve how we assure quality
Responsible for all aspects of daily dose mapping and dosimetry
Maintain a robust operational quality process
Demonstrated experience as a hands-on critical thinker
Strong organizational & planning skills
Excellent communication skills, for managing both up and down
Required Education & Experience
4+ years in a quality manufacturing role
BA/BS in engineering or natural sciences
Ideal skills / past experiences
Experience working in radiation sterilization
Experience beginning in a startup environment and scaling to a mature business
Masters degree in microbiology or related field
Experience working with ISO 13485 and ISO 11137 standards
NextBeam is a startup company on a mission to fundamentally improve how radiation sterilization is done. We are currently building out our initial, 30kW/10MeV electron beam sterilization facility in North Sioux City, South Dakota.At NextBeam, we value teammates that are honest, clear-minded, customer-oriented problem solvers. We seek colleagues that naturally have an ownership mentality, exhibit strong attention to detail, can think both tactically and strategically, and aren’t afraid to get their hands dirty.