Job Summary The Quality Engineer will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Duties and responsibilities Develop and maintain strong internal working relationships across the company. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Assist with the Corrective/Preventive Action (CAPA) program. Assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Performs other related duties as assigned. Qualifications and experience Required Skills: 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. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. Excellent organizational skills, with the ability to prioritize work. Education and Experience: Bachelor of Science in Engineering, Science, or Biomedical. Minimum 3 months to 2 years of experience with a comprehensive knowledge of Medical Device regulations including FDA 21 CFR 820 and other applicable international standards with hands on experience in working within a quality system under regulatory requirements including a background in device design, testing, and FDA clearance. Proficiency with Microsoft Office (Word, Excel, PowerPoint). Ability to travel as needed (≤ 10% of the time). ASQ CQE and CQA Certifications or related quality/regulatory certification a plus. Physical Requirements: Position may involve the use of basic hand tools and inspection and cleaning equipment Position may involve handling of or exposure to metallic powders, mill coolant, tapping fluid, and polymeric resins. Limited physical requirements other than general skills required to participate in laboratory experiments, production activities, or other similar activities. Standard working conditions, including office environment, laboratory, aseptic surgical (when visiting surgical centers and viewing surgeries), and general travel. Prolonged periods sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times.