Quality Engineer II

The Quality Engineer II (QE II) will be an integral member of the BiVACOR quality team, supporting quality-related activities associated with the manufacture, testing, and distribution of the Total Artificial Heart (TAH) system. The QE II will also work with BiVACOR senior management to implement and support maintenance of the quality management system in accordance with ISO 13485 and 21 CFR 820, 803, and 806.

The QE II will assist in the management of daily QA activities, including developing and performing validation & verification tests, as well as completing incoming, in-process, and final inspections of assemblies and devices. The QE II will collaborate with internal engineering staff from mechanical, electrical, and software engineering backgrounds to support the development and maintenance of manufacturing processes. The QE II may also assist with elements of design control, such as requirements, system hazards analysis, design, and process FMEAs.

The QE will act as a liaison between the company and external suppliers to ensure that QA activities are sufficiently undertaken to support product development. They will identify and record potential problems relating to the product, process, and Quality System. QE II will initiate, recommend, or provide solutions through designated channels and will then record and/or report all instances of customer feedback on the product.

QE II will finally verify the implementation of solutions.

KEY RESPONSIBILITIES

Quality System Management

• Ensure that the Quality System is compliant with 21 CFR 820, 803, and 806, as well as ISO 13485.
• Promote awareness of the Quality System and provide training to individuals across the organization on quality management philosophies, tools, techniques, and best practices.
• Support training and direction, as required, to junior team members within the organization.
• Implement quality methods throughout the organization, drive the use of quality tools in operation and product development, and assist in resolving major product-related issues.
• Create, edit, and maintain documentation related to design controls and quality system guidelines.
• Assist in the development of design input specifications and study designs.
• Write and review Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Support product and process quality in accordance with quality principles, which include material control, acceptance sampling, and measurement systems.
• Assist in the development and validation of test methods that address User Needs and Design Specifications.

Risk Management and Compliance

• Support the preparation and maintenance of compliance with ISO 14971 Risk Management. Assist in conducting risk management activities and updating FTA, FMEA, etc.
• Coordinate and oversee sterilization validation activities.
• Coordinate and oversee maintenance of clean room environments (min. class
  7).
• Review and approve Device History Records
• Assist with the implementation and validation efforts for new facility location, new/changed materials, equipment, processes and components

Process Validation and Testing

• Support or lead validation activities, including IQ, OQ, and PQ for manufacturing processes
• Support or lead test method validation (TMV) and ensure accuracy in quality testing.
• Analyze quality data trends to drive process improvements.
• Assist in the development and validation of test methods that address User Needs and Design Specifications.
• Coordinate and oversee sterilization validation activities.
• Coordinate and oversee maintenance of clean room environments
• Review and approve Device History Records.
• Assist with the implementation and validation efforts for new facility location, new/changed materials, equipment, processes, and components.
• Support systematic planning and control of product and process quality in manufacturing.
• Conduct inspection of components and subassemblies as required and document compliance with approved specifications and procedures.
• Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods, and environmental conditions.

Quality

• Conduct supplier audits and manage supplier corrective actions.
• Support production teams in resolving non-conformance issues.
• Interact with external suppliers.
• Develop quality agreements and quality control plans in collaboration with suppliers.
• Support Lean and Six Sigma methodologies to enhance efficiency.
• Drive initiatives to reduce defects, improve yield, and optimize processes.
• Support strategies for cost-effective quality improvements.
• Support quality improvement models, corrective and preventive action, and overcoming barriers to quality improvement.
• Participation in external audits – develop a response to queries during and following the audit.
• Initiate action to prevent the occurrence of non-conformities relating to the product, process, and quality system, and follow through the non-conformance and failure investigation process affecting Quality, and report verbally and in writing to the executive team…