You need: Your BA/BS Engineering-oriented degree and 2+ years of experience in the medical device manufacturing supplier controls, or 4+ years of experience in the medical device manufacturing supplier controls ASQ Certified Quality Engineer, preferred Certified Auditor, preferred Auditing experience is required, preferably in the area of supplier audits Understanding of and ability to interpret and apply ISO 13485, ISO 14971, and 21 CFR Part 820, specifically design controls, purchasing controls, risk management and production and process controls Proficiency leading CAPA investigations and supplier corrective action Strong interpersonal relationship skills including negotiating and relationship management Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint) Excellent written and verbal communication skills Ability to work as a collaborative team member as well as independently Excellent attention to detail, producing high quality output Results-oriented with appropriate urgency and tenacious follow-up Flexibility and strong organizational skills with ability to prioritize multiple tasks Sound judgment when making decisions and communicating with internal and external customers. OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Supplier Quality Engineer responsible for managing supplier programs for manufacturing, packaging, and other operational processes, as well as ensuring that quality programs are in compliance with regulatory requirements.