Job Summary
Product Software Quality Engineering – Job descriptionRoles / ResponsibilitiesEnsuring Design Control and Risk Management activities comply with applicable processes and regulatory requirementsActing as a Design Quality team member supporting new product development and lifecycle management activitiesProviding guidance on medical device regulations and design control requirements across global marketsPartnering with design teams to define design inputs and outputs, support verification and validation activities, and contribute to process validation, design transfer, and launch planningEnsuring critical‑to‑quality requirements are identified and translated into design and process specificationsManaging and delivering quality outputs for R&D projectsSupporting design reviews and maintaining accurate design control recordsReviewing and approving R&D and production batch documentation, including sterilization records, to support timely project progressionMonitoring Quality Management System data and identifying trends or issuesLeading or supporting quality system improvement activities, including CAPA and nonconformance managementSupporting internal and supplier audits and participating in inspections as neededCollaborating with Regulatory Affairs on submissions and deliverablesSupporting complaint investigations, escalation activities, and post‑launch CAPA where requiredQualifications / RequirementsDegree in an engineering or technical disciplineMinimum 5 years of experience in the medical device, IVD, or pharmaceutical industryExperience working with Quality Management Systems and design control processesStrong knowledge of design control, risk management, sterilization, and quality assurance processesWorking knowledge of 21 CFR 820 and ISO 13485, with familiarity of global regulatory requirementsExperience preparing for and participating in regulatory inspections (e.g., FDA, Notified Body)Ability to manage multiple projects and prioritize effectively in a dynamic environmentStrong problem‑solving skills and ability to identify and address key quality risksAbility to work independently and collaboratively within cross‑functional and global teamsClear communication skills, with the ability to present complex information in a structured wayAbility to build strong working relationships across functions such as Product Development, Regulatory Affairs, Manufacturing, and MarketingDemonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity
Key Responsibilities
Acting as a Design Quality team member supporting new product development and lifecycle management activitiesProviding guidance on medical device regulations and design control requirements across global marketsPartnering with design teams to define design inputs and outputs, support verification and validation activities, and contribute to process validation, design transfer, and launch planningEnsuring critical‑to‑quality requirements are identified and translated into design and process specifications
Skill Requirements
design quality, SW Qaulity , risk management, IEC 62304