Sr. Quality Assurance Engineer (ISO 13485)
Description
- 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.
- 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.
ABOUT US
ORB Innovations is a London-based startup making waves in the world of contact and combat sports. With a passion for innovation, ORB makes Smart Mouthguards that protect athletes teeth AND track their fitness, performance and wellness, providing valuable data to help them train smarter and push further... What's a Smart Mouthguard? Imagine a Fitbit, in a mouthguard!
ORB's products are the first and only of their kind, from heart-pumping beats to head-turning impacts, we've got these athletes covered with a wearable that's tailored to their sport.
Founded in 2017, ORB has spent over 5 years tirelessly working to bring this groundbreaking technology to market. Now, as ORB expands its team, join us in bringing the future of sports technology to athletes everywhere.
THE INTERVIEW PROCESS
Our process involves three stages:
- Resume Review & Short List.
- Initial Call (Depending on the role, a take home task may also be requested).
- Final Interview.
Our average process takes approximately 2-3 weeks, but we always work around your availability.
You will have the chance to speak to our recruitment team at various points during your process but if you do have any specific questions or want to talk through reasonable adjustments ahead of or during your application, please contact us at [email protected].
WHAT'S IN IT FOR YOU
We're a hardware enabled sports analytics startup with an expanding passionate team, collaborating and creating extraordinary physical & digital products that have the potential to make a significant difference to our customers lives. If you love sports and technology, this is where the two meet!
There are loads of ways we help ORB-ians do the best work. We often review and enhance our benefits, but here's a brief overview of what we offer right now. If you'd like more information on any of them, just ask!
You can see a full list of employee benefits at https://orbsport.com/pages/careers.
EQUAL OPPORTUNITY STATEMENT
We are actively creating an equitable environment for every ORB-ian to thrive.
One of our priorities is to promote diversity and inclusion, ensuring that we provide ample support for all our employees to grow within the company. Embracing diversity in all its forms and fostering an inclusive environment are essential to our ethos.
As an equal opportunity employer, we consider all applicants for employment without any bias based on ethnicity, religion, sexual orientation, gender identity, family or parental status, national origin, veteran status, neurodiversity status, or disability status.