Senior Quality Engineer

My Client is a clinical-stage, venture-backed medical device company that is developing bioresorbable polymer wraps to improve vascular surgery outcomes. As a clinical-stage medical device company that is making improvements to its Quality Management System (QMS), we are seeking a detail-oriented and motivated Senior Quality Engineer to join our Quality team. This role will be responsible for streamlining the QMS as well as providing Quality Engineering support for various ongoing work and projects.

The ideal candidate will have strong organizational skills, an interest in developing a QMS within a medical device company, and the ability to improve quality culture throughout the company.

• Implement, maintain, and streamline QMS processes that include but are not limited to NCRs and CAPAs, Supplier Management, Audits, and Training.
• Participate in and support product Design Control activities to ensure that manufactured devices meet design specifications and conform to appropriate industry standards.
• Ensure DMR, DHF, and DHRs are developed and updated throughout advancement of relevant product design and production process.
• Maintain and, as needed, revise product Risk Management profiles and documentation.
• Ensure adherence to quality standards and regulatory requirements during all phases of product development and PMA approval.
• Establish and improve supplier relationships via the supplier management process to provide assurance and control over purchased products and services.
• Prepare, conduct, and support audits to monitor compliance with internal policies and to ensure compliance with regulatory requirements and industry standards as required.
• Provide support during nonconformance investigations and conduct root cause analysis of quality problems to determine appropriate solutions.
• Assist with Document and Change Management Control in the eQMS.
• Support clinical builds and distribution with respect to the company’s clinical study goals.
• Collaborate with Engineering team to develop, optimize, and validate manufacturing processes.
• Uphold a culture of quality and compliance within the organization through training, guidance, and continuous improvement initiatives.
• Identify and implement new technologies to improve processes efficiency, reduce costs, and increase productivity.

• 4+ years of Quality Engineering experience in the medical device industry.
• Working knowledge of medical device regulations: FDA 21 CFR 820, ISO 14971 & 13485 as well other applicable regulations and industry standards pertaining to medical devices.
• Strong analytical, problem-solving, and organizational skills.
• Proficiency in Microsoft Office (Excel, Word, Outlook).
• Excellent communication and teamwork skills.