Design Quality Lead - Medical Device Software

Design Quality Lead - Medical Device Software at Pharmaceutical Company Design Quality Lead - Medical Device Software at Pharmaceutical Company in Woodbridge, Connecticut Posted in 1 day ago.

Type:

full-time

Job Description:

The ideal candidate will have strong expertise in medical device quality systems, design controls, AI/Software Medical Devices, and global regulatory standards including

ISO 13485, IEC

62304, IVDR/MDR, and

FDA 21 CFR

Part 820. Responsibilities Provide quality oversight for AI SaMD / DHT development programs and external business partners. Develop and maintain QMS procedures, SOPs, and quality guidance documents aligned with

ISO 13485, IEC

62304, IVDR, and FDA QMS requirements. Ensure compliance with design control requirements throughout the product lifecycle. Support supplier qualification and operational due diligence activities. Review and approve key deliverables including DHF documentation, CAPA, risk management, change controls, and design reviews. Collaborate with cross-functional teams including Product Development, Regulatory Affairs, and Quality. Support global regulatory submissions including 510(k), De Novo, and PMA activities. Participate in audit readiness activities, inspections, and compliance initiatives. Required Qualifications Bachelor's degree in Engineering, Science, or related field. 7+ years of experience in medical device or SaMD quality environments. Strong knowledge of Design Controls and medical device lifecycle processes. Experience with

ISO 13485, IEC 62304, FDA 21 CFR

Part 820, MDR/IVDR. Experience supporting AI-enabled medical device or digital health products. Strong communication, stakeholder management, and project coordination skills. Preferred Qualifications Experience supporting regulatory approvals including 510(k), De Novo, or PMA. Experience working with AI-based Digital Health Technologies or Software as a Medical Device. Prior experience working with external development partners or suppliers.