Sr. Quality Assurance Engineer

Description Position at Prismatik We're looking for a Sr. QA Engineer to help build quality into every stage of our medical device development and manufacturing. You'll have broad ownership across quality engineering, risk management, CAPA, validation, and our Quality Management System. Working closely with cross-functional teams, you'll solve complex quality challenges, support new products and processes, and help ensure what we build meets the highest standards for safety, performance, and compliance. Essential Functions : Ensure compliance with applicable regulatory standards, including FDA 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR. Lead and support CAPA investigations, non-conformance management, and root cause analysis using tools such as 8D, Fishbone, and 5 Whys. Own and continuously improve elements of the Quality Management System (QMS), including document control, internal audits, supplier quality, and change control. Collaborate cross-functionally with R&D, Manufacturing, and Regulatory Affairs to support design control, risk management (ISO 14971), and product development lifecycle activities. Lead internal and supplier audits, and support external audits and inspections (e.g., FDA, Notified Bodies). Participate in validation activities (IQ/OQ/PQ) for processes, equipment, and software used in manufacturing and quality operations. Develop, monitor, and analyze quality metrics to identify trends, drive continuous improvement, and ensure effectiveness of corrective actions. Provide quality engineering support to Quality Control, including guidance on inspection methods, metrology, and measurement system capability. Conduct and document investigations of NCRs, complaints, and deviations, providing effective and sustainable corrective and preventive actions based on engineering analysis. Lead and mentor junior engineers, fostering technical growth and reinforcing a culture of quality and compliance. Integrate ISO 14971 risk management and IEC 62366 usability engineering activities within Glidewell/Prismatik processes. Ensure organizational compliance with the QMS through ongoing training, education, and internal communication. Collaborate with Manufacturing and Engineering to coordinate pilot production, process validations, and risk analyses for new products and processes. Ensure calibration and preventive maintenance systems meet compliance and operational requirements. Identify and implement process optimizations using Lean and Six Sigma methodologies to improve manufacturability, reduce risk, and enhance efficiency. Identify opportunities for design or re-design of equipment, tools, and fixtures to improve manufacturing processes and product quality. Perform other related duties and special projects as assigned by management. Minimum Qualifications: Bachelor's degree in Engineering, Science, or a related technical field. Minimum of 5 years of experience in Quality Assurance or Quality Engineering within the medical device industry, or equivalent education and experience demonstrating comparable skills and knowledge. Strong working knowledge of FDA regulations, ISO 13485, and other applicable international quality standards. Hands-on experience with risk management (ISO 14971), design controls, and validation methodologies. Proven analytical, problem-solving, and communication skills. Proficiency in quality and statistical analysis tools such as Minitab or equivalent software. Demonstrated project management experience. Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma certification, preferred. Experience with combination products or Class I/II medical devices, preferred. Familiarity with EU MDR and UDI regulatory requirements, preferred. Pay range: $99,000 - $120,000/yr. Exact compensation may vary based on skills and experience. This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available. Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell! In addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more! Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected]. Please indicate the specifics of the assistance needed. Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form. Prismatik