Sr Design Quality Engineer II

Description The Senior Design Quality Engineer provides dedicated quality engineering support for development activities performed on behalf of customers, including new product introductions, product line extensions, and technology transfers into the site. This role ensures that quality requirements are effectively integrated into product and process design activities, in partnership with cross‑functional teams and customers, within a contract manufacturing environment. Responsibilities Provide quality engineering leadership for customer‑sponsored development activities, including new product introductions, product line extensions, and technology transfers, acting as the primary quality interface for assigned programs and representing Quality in customer interactions related to development activities. Embed quality and risk‑based thinking into product and process development activities by partnering with cross‑functional teams and customers to ensure compliance with applicable quality standards and regulatory requirements, including leadership or support of formal risk management activities. Collaborate with Supply Chain and Supplier Quality to support supplier selection, material qualification, and supply chain readiness for development programs and transfer into manufacturing. Define and oversee quality strategies and requirements for process development, verification, validation and testing activities, ensuring alignment with quality, regulatory and customer needs. Provide structured quality risk and compliance input (as applicable) to the NPD/NPI stage‑gate process. Provide quality input to product and process changes during development and transfer, ensuring changes are appropriately assessed, documented, and controlled. Support structured and controlled transfer of products and processes into operations, maintaining continuity of quality oversight through early production whilst clearly transitioning ownership to Operations Quality. Contribute to the development and standardization of Design Quality practices, frameworks and tools, providing technical leadership, coaching, and mentoring as required within the Quality Engineering team. Qualifications Required Bachelor's degree in a scientific, engineering or related technical discipline. Minimum 7 years of experience in Quality Engineering within a regulated manufacturing environment. Strong understanding of applicable quality standards and regulatory requirements e.g. ISO 13485, FDA 21 CFR 820, FDA 21 CFR 210/211. Proven experience supporting new product introductions, product line extensions, and/or technology transfers. Practical experience applying risk‑based quality principles to development, validation, and transfer activities. Experience representing Quality within cross‑functional project teams, including customer‑facing interactions. Preferred Experience working in a Contract Manufacturing Organization (CMO) or comparable environment delivering development or technology transfer activities on behalf of customers. Exposure to formal NPD/NPI governance models (e.g. stage gate reviews). Competencies Proven ability to influence and collaborate with cross‑functional teams. Excellent communication, coaching and problem‑solving skills. Highly organized and diligent. Acts as a role model for quality culture. #J-18808-Ljbffr BioMed Laboratories LLC