Job Description

As the Sr. Quality Engineer, you will participate in the implementation and maintenance of QSR (21 CFR 820) and ISO 13485 quality systems and qualification activities of CellFX System, surgical disposable and reusable medical devices in support of the Company’s research and development, manufacturing, regulatory, and clinical affairs efforts. In addition, this individual will support the development and implementation of quality systems and compliance activities.

To Make An Impact, You Will:

• Provide expertise and guidance to product development and manufacturing teams in the areas of design assurance, design controls and compliance.
• Develop, establish, and maintain quality engineering methodologies, systems and practices that our’ customer and regulatory requirements.
• Lead the risk management process in establishing risk management plan, conducting risk evaluation and analysis, and creating risk management report.
• Lead the process in establishing product traceability matrices, conducting requirement trace verification and analysis, and creating trace matrix reports.
• Manage all aspects of biocompatibility testing and sterilization including creating of test protocols and executing of testing.
• Proactively investigate, identify, and implement best-in-class quality engineering practices.
• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
• Develop and validate measurement methods, monitor design control standards, facilitate, and perform statistical analysis, and participate in MRB as appropriate.
• Lead the review of process and product quality performance, working in concert with various departments.
• Assist with development of product labeling, UDI compliance, translation, and investigator brochures for commercial and clinical studies.
• Design and implement methods and procedures for inspecting, testing, and evaluating components, sub-assemblies, and final assemblies.
• Support management review activities, regulatory audits including Notified Body audit (MDSAP) and assist with preparation of regulatory submissions.
• Carry out responsibilities in accordance with the organization’s policies and applicable laws.
• Support the Quality Policy and Quality System.

To Excel, You Will Bring:

• BS degree in Engineering, Science or a related field.
• 5 years of progressive quality engineering experience with Class II/III products in the medical device industry.
• Cardiovascular device experience is strongly preferred.
• Must have extensive work experience with FDA QSR (21 CFR Part 820 & Part 11) and ISO 13485/MDR requirements are required.
• Must have extensive knowledge and experience in Risk Assessment (ISO 14971) practices and implementation.
• Knowledge and experience in ISO 10993 standard series (Biocompatibility), AAMI/ISO 11135 & 11137 (EO & Irradiation sterilization), ISO 11607 & ASTM D4169 (Sterile Packaging & Performance Testing).
• Hands-on experience with medical devices from development through commercialization is highly desirable.
• Experience working in a start-up environment a plus.
• Mastered the use of quality disciplines, tools, and methodologies.
• Proficient knowledge and skill in Microsoft Office Suite applications.
• Excellent oral written communication skills and critical thinking skills.
• Ability to work conscientiously and with minimal direction, using good judgement, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
• Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company.
• Ability to travel up to 10% of the time. Overnight and/or international travel may be required.
• Ability to lift 10-15 pounds.

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