OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Senior Design Quality Engineer. This role spearheads design quality activities, ensuring the products are safe, effective, and compliant with regulatory requirements. The role also leads design validation and verification processes, conducts comprehensive risk management, including risk analysis and control, performs human factors analysis, and oversees component qualification. The DQE may also provide critical support product-related Corrective and Preventive Action (CAPA) investigations tied to product design.

You will:

Provide expert guidance to the design team on quality assurance, design and development controls, specification development, test method development, usability engineering, and risk management processes. Lead the product quality team's efforts in design reviews and technical reviews, ensuring that design and verification activities are planned, executed, and documented in accordance with OrthAlign's standard operating procedures. Oversee the compilation and maintenance of Design History Files (DHF) and Device Master Records (DMR) to ensure compliance with regulatory requirements and support product development. Drive risk management activities, including risk analysis and control, to ensure product safety and effectiveness throughout the design lifecycle. Conduct human factors analysis to optimize usability and mitigate potential use-related risks in orthopedic device designs. Collaborate with cross-functional teams to integrate quality principles into new product development and on-market support. Determine appropriate sample sizes for design verification and validation testing, as well as inspection processes, based on risk assessments. Apply statistical methods and quality engineering principles to ensure robust product quality and compliance with regulatory standards. Lead CAPA investigation teams associated with failure investigations including identification and completion of corrective actions Identify, propose and drive opportunities for improvement, including review and revision of procedures, test methods, product design, and associated documents Support audits of the quality management system, specifically relating to design control, risk management, CAPA, complaints, and related processes. Support regulatory submissions reviewing content for accuracy and comprehensiveness. Support other quality system activities as directed by management. You need: Your BS/BA degree and 7 years of experience in medical device design or, 15 years experience without a degree ŸIn-depth knowledge of Design Controls (21 CFR 820.30) and Risk Management (ISO 14971) ŸStrong background with experimental and inspection sample size determination ŸStrong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint) ŸExcellent written and verbal communication skills ŸResults-oriented with appropriate urgency ŸAbility to work as a collaborative team member as well as independently ŸExcellent attention to detail, producing high quality output ŸFlexibility and strong organizational skills with ability to prioritize multiple tasks ŸApplies sound judgment when making decisions and communicating with internal and external customers ŸAbility to read and understand technical documentation including engineering schematics, manufacturing instructions, and test protocols ŸGood understanding of CAPA investigations and risk assessments ŸStrong interpersonal relationship skills including negotiating and relationship management ŸExperience in the development and performance of electronic medical device products design V&V testing (preferred) ŸExperience with problem-solving methodologies including Design of Experiments, basic statistics, graphical analysis, hypothesis testing, and process mapping (preferred) ASQ Certified Quality Engineer (preferred) We offer: Competitive compensation including bonus and equity Opportunities for career advancement Full benefits package An evolving, engaging culture and workplace Nominated by our employees as a Top Place to Work in Orange County!

It is an exciting time at OrthAlign - make your next career move with us!

Please note that we are unable to provide any type of sponsorship at this time.