Job Summary: The Product Quality Engineer will be responsible for product quality engineering/ quality assurance activities. This includes interpretation and implementation of quality standards to routine manufacturing, continuous improvement, and product release activities. Essential Duties and Responsibilities: • Develop and maintain strong internal working relationships across Conformis. • Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. • Prioritize and plan work activities; adapt for changing conditions. • Perform quality testing of CER and Purified water system. • Perform product release activities (on an as needed basis). • Administers the bioburden/endotoxin testing program as required per procedure. • Trend in-process manufacturing data and environmental monitoring data and produce summary reports. • Implement and maintain quality system in accordance to applicable regulatory requirements. • Initiate and participate in resolution of non-conforming materials. • Review Non-Conformity Reports for sub-assemblies and finished goods. • Administer the calibration system. • Review of the daily activities for production start-up. • Develop and upgrade procedures for continuous improvement as required by the quality system. • Perform Internal Quality Audits of the quality system. • Develop qualification/validation plans. • Conduct product/process validations (sterilization). • Develop and implement statistical sampling plans. • Assist in the investigation of product complaints. • Assist in corrective action investigations. • Perform internal audits to drive continuous improvement (minimum of 2 per year). • Other responsibilities as assigned. Qualifications: • Bachelor of Science in Engineering or Science. • 1-3 years of Quality Assurance/Quality Engineering and experience in a FDA regulated environment is preferred – with QSR (21 CFR Part 820) experience if possible (Job Specific Qualifications). Skills, Abilities, Competencies Required: • Excellent written and verbal communication skills. • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. • Strong organizational, analytical, and time-management skills. • Able to self-motivate and work both independently and as part of a team. • Must have a solid knowledge of Microsoft office 2010. • Knowledge of FDA and ISO standards for Medical Devices is a plus. • Knowledge of Statgraphics or Minitab is a plus. Conformis is an Equal Opportunity Employer