61 Management Responsibilities
Responsible for daily management of staff reporting to this position, which may include one or more Quality Engineers and one or more technical writers.
All responsibilities described below are carried out by this position and his/her direct reports.
61 Production Quality:
Provides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and analysis for BrioVAD products.
84 Supports and monitors the incoming, in-process and final inspection activities and associated processes for BrioVAD products manufactured at the Suzhou facility.
84 Helps implement and maintain quality assurance processes for BrioVAD to ensure compliance with applicable regulations and standards, such as ISO 13485, FDA QSR, and other relevant guidelines.
Supports the Material Review Board (MRB) meetings for BrioVAD products manufactured at the Suzhou facility; helps identify compliance gaps, conducts root cause analysis and corrective actions for non-conforming components.
Ensures that product quality meets applicable requirements and device history records are complete prior to product lot release.
Initiates and executes Engineering Change Orders (ECOs) for areas of responsibility.
Adheres to and promotes adherence to established procedures.
61 Design Transfer:
Works closely with BHS R&D, Design Quality and Advanced Manufacturing Engineering (AME) to transfer products to the Suzhou manufacturing facility.
Supports the AME/operations team with developing and implementing manufacturing plans to accomplish a robust design transfer from initial concept to full production for new products, product changes and enhancements.
Supports the AME/operations team with designing and developing manufacturing processes, associated equipment, tooling, and fixtures to meet business needs while enhancing process safety, quality, and productivity.
Collaborates with the operations team to incorporate risk management principles into the process design and facilitate risk-based decision making.
Assists the operations team with conducting process design and risk reviews to assess compliance with regulatory requirements, industry standards, and internal quality procedures.
Plays a key role in drafting and finalizing pFMEA, DFM/DFA, and process control strategies.
Assists with creation, execution and completion of all process validation activities for BrioVAD products (e.g., process development and execution of IQ/OQ/PQ).
61 Process Support and Improvement:
Provides support to the AME/operations team in troubleshooting, implementing production throughput and yield improvements, training on new products or processes, verifying documentation compliance.
Supports the creation of training materials and execution of training for BrioVAD manufacturing personnel for newly developed processes as needed.
Reviews and help maintain Manufacturing Procedures, Test Procedures, Calibration Procedures, and Quality Control Procedures and Instructions for BrioVAD products.
61 Supplier Management:
Assists the supply chain team with building and maintaining strong relationships with suppliers for manufacturing materials, processes and equipment.
Assists with identification and qualification of alternative suppliers, as needed.
Assists AME and supply chain teams with implementing supply chain sustaining and cost reduction activities.
Collaborates with suppliers to ensure their processes and products meet the necessary quality standards and regulatory requirements.
Participates in supplier audits and assessments, addressing any identified non-conformances or quality issues.
Supports supplier qualification and selection processes by evaluating their quality systems, capabilities, and performance.
61 Cross-functional Collaboration:
Applies persistence and determination in organizing, managing, and motivating, cross-functional teams to implement and integrate new process technologies to help improve product quality.
Works closely with various departments, including R&D, design quality, manufacturing, supply chain, and regulatory affairs, to understand and address their needs.
61 Other:
Identifies technical risks, resource issues and proposed solutions while continuing to build trust at all levels of the organization.
Collaborates with cross-functional teams to ensure adherence to design control processes throughout the product development lifecycle, including planning, design inputs, design outputs, verification, validation, and transfer to manufacturing.
Applies risk management methodologies, such as ISO 14971, to identify, evaluate, and mitigate risks associated with the manufacturing process and use of medical devices.
Conducts process audits and assessments to verify compliance with manufacturing procedures and quality management system requirements.
Performs statistical analysis and trending of quality data to identify areas for improvement and implement corrective and preventive actions (CAPAs).
Participates in BrioVAD manufacturing process audits and assessments.
Supports regulatory inspections and audits, addressing any findings and implementing appropriate corrective actions.
Stays updated with relevant regulations, guidelines, and industry best practices pertaining to medical device design, development, and quality assurance.