Principal Design Quality Assurance Engineer, Technology Transfer - Alpharetta, GA;

Career Opportunities:
Principal Design Quality Assurance Engineer, Technology Transfer
- Alpharetta, GA (7166)

Requisition 7166 - Posted
- Alpharetta Office
- United States
- Quality Assurance, Regulatory & Compliance
- Georgia

Job Title Principal Design Quality Assurance Engineer, Technology Transfer
- Alpharetta, GA

Job Country United States (US)

The purpose of this position is to focus on the quality‑related design transfer activities to ensure the smooth quality and technical transfer of design, products and processes from R&D and sustaining engineering to full‑scale (internal or external) manufacturing compliant to medical device standards and regulations such as FDA 21 CFR Part 820 QMSR, ISO 13485, and EUMDR.

The position will focus on the Design Transfer of new to market medical devices and products going through the full design and development process and of existing products in the field going through design changes. Transfer can be both to internal manufacturing facilities or to qualified suppliers and contract manufacturing organizations.

• Ensure all design specifications, drawings, and procedures are accurately translated to production specifications and processes with the establishment of a Medical Device File (MDF) and the Bill of Materials (BOM).
• Be responsible for Design Transfer Plans, Reviews and Reports including Final Design Transfer activities.
• Collaborate with R&D, Sustaining Engineering, Technical Operations, Supplier Quality, Manufacturing, Supply Chain, Procurement and Regulatory teams to define quality requirements that will ensure the successful execution of design transfer from the device design to full‑scale manufacturing and commercial launch.
• Facilitate process development and Design for Manufacturing (DFM) processes with R&D, Sustaining Engineering and Technical Operations.
• Partner with Supplier Quality and Supply Chain to facilitate the qualification of supplied raw materials and components.
• Collaborate with Technical Operations, Manufacturing Operations and Manufacturing Quality to establish and define incoming, in‑process and finished product inspection and testing and acceptance criteria.
• Support risk analyses (e.g., pFMEA) related to production including the development of control plans.
• Participate in design reviews, providing expert quality input for the transfer phase and ensuring adherence to design control procedures and relevant medical device regulations (e.g., ISO 13485, FDA QMSR).
• Ensure smooth transfer of new products from development to manufacturing, including the establishment of quality control points and documentation which may include:

Review and approval of manufacturing test protocols and inspection plans.

Review and approval of Test Method Validation and process capability analyses for new manufacturing processes.

Review and approval of process validation protocols and reports.

Review and approval of work instructions and job aids to ensure quality conformance of the manufacturing and inspection process(es).

• Work with suppliers and contract manufacturers as needed to support design transfer, ensuring they meet Avanos’ requirements and quality standards.
• Investigate and resolve quality issues identified during the design transfer phase.
• Ensure the design and development files are kept current during the design transfer phase and contribute as needed to the risk management file development.
• Contribute to continuous improvement initiatives within the Quality department and support QMS audits.

• Master’s degree in Engineering (e.g., Biomedical, Mechanical, Electrical, Industrial) or a related technical field.
• At least 7 years of experience in quality engineering within the medical device industry, with a strong focus on development and production.
• Experience and knowledge of 21 CFR Part 820 QMSR (Quality Management System Regulation), ISO 13485 and ISO 14971.
• Experience and knowledge of process validation, supplier quality, test method validation.
• Experience with injection molding, extrusion, welding, curing, bonding, sterilization and assembly processes.
• Excellent problem‑solving skills and the ability to…