Principal Design QA Engineer, Technology Transfer

Salary: $72000 - 114000 per year Requirements: We require a masters degree in engineering or a closely related technical discipline such as biomedical, mechanical, electrical, or industrial engineering. We are looking for at least 7 years of quality engineering experience in the medical device industry, with strong exposure to both development and production environments. We need hands-on knowledge of 21 CFR Part 820 QMSR, ISO 13485, and ISO 14971. We expect experience with process validation, supplier quality, and test method validation. We require familiarity with injection molding, extrusion, welding, curing, bonding, sterilization, and assembly processes. We are seeking strong problem-solving ability and the capability to perform root cause analysis. We need excellent technical writing skills and experience producing clear documentation. We require demonstrated expertise in design controls, risk management, design verification, and process validation activities such as IQ, OQ, and PQ. We require fluency in English, both written and spoken. We require the ability to travel internationally up to 10% of the time. This role is based in Alpharetta, GA, and we need someone who can work in the office at least three days per week, ideally Tuesday through Thursday, and attend onsite workshops when needed. Preferred qualifications include fluency in Spanish, ASQ CQE or Six Sigma Green/Black Belt certification, and experience in Design for Manufacturing and supplier controls. Responsibilities: We lead quality-focused design transfer activities to ensure smooth technical and quality transfer of designs, products, and processes from R&D and sustaining engineering into full-scale manufacturing. We translate design specifications, drawings, and procedures into production specifications and manufacturing processes, including the creation of the Medical Device File and Bill of Materials. We own Design Transfer Plans, Reviews, Reports, and final transfer activities. We partner with R&D, sustaining engineering, technical operations, supplier quality, manufacturing, supply chain, procurement, and regulatory teams to define quality requirements for successful design transfer and commercial launch. We support process development and design for manufacturing efforts with cross-functional partners. We work with supplier quality and supply chain teams to qualify raw materials and components. We collaborate with technical operations, manufacturing operations, and manufacturing quality to establish incoming, in-process, and finished product inspection and testing criteria. We support risk analyses such as pFMEA and help develop control plans. We participate in design reviews and provide quality expertise to ensure compliance with design control procedures and medical device regulations. We help ensure a smooth transition of new products from development to manufacturing by defining quality control points and related documentation. We review and approve manufacturing test protocols, inspection plans, test method validation, process capability analyses, process validation protocols and reports, work instructions, and job aids. We work with suppliers and contract manufacturers to support design transfer and ensure alignment with our requirements and quality standards. We investigate and resolve quality issues arising during the design transfer phase. We keep design and development files current and contribute to risk management file development as needed. We support continuous improvement initiatives within the Quality organization and assist with QMS audits. Technologies: Support Excel More: We are Meridian Softworks, a medical device company headquartered in Alpharetta, Georgia, focused on delivering clinically superior breakthrough solutions that help patients get back to what matters most. We develop, manufacture, and market recognized brands in more than 90 countries, with a strong commitment to innovation, healthcare impact, and improving outcomes such as reducing opioid use while supporting recovery from surgery. We offer a collaborative, independent culture, comprehensive and competitive total rewards, benefits from day one, a 401(k) employer match with immediate vesting, a free onsite gym, an onsite cafeteria, and a headquarters region voted a best place to live by USA Today. last updated 26 week of 2026