Lead Specialist, Quality, Digital

Role: Lead Specialist in Digital Quality focusing on software products, cloud solutions, and digital platforms within biopharma-related healthcare technology. Responsibilities: provide quality guidance across product lifecycle stages—requirements, design, development, verification, validation, release, and maintenance; support regulated software, SaaS, APIs, and digital health platforms; evaluate product risks, implement scalable quality controls within Agile and DevSecOps frameworks; review documentation, perform risk management, and support audits and investigations; develop procedures and metrics to enhance quality processes and foster a quality-centric culture. Qualifications: Bachelor’s in Engineering, Computer Science, or related field, or 10+ years relevant experience; 6+ years in software quality, engineering, or digital product development supporting Agile/DevSecOps environments; strong understanding of software lifecycle principles, risk management, and regulatory standards such as IEC 62304, ISO 13485, and FDA software guidance. Preferred: experience in medical device software, healthcare tech, cloud-native applications, AI/ML-enabled software, and familiarity with standards like IEC 82304-1 and ISO 14971. HighValue: regulated healthcare digital products, cloud-based SaaS, AI/ML, software validation, risk management, compliance with medical device software standards. WorkSetup: not specified.