Senior Software Quality Engineer – Non-Product Software

About Sequel

Sequel, headquartered in Manchester, New Hampshire, is a company developing the next generation of transformative drug‑delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel’s flagship product, the twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type 1 diabetes providing them with personalized diabetes management.

We are looking for an experienced

Senior

Software Quality Engineer to support the validation of non-product software systems and tools within the quality management system (QMS).This role will ensure compliance with FDA regulations and medical device industry best practices, oversee quality approvals, and support product release. The ideal candidate will be asubject matter expert (SME) innon-product software validation within a highly regulated environment.

• Support software validation and verification efforts to ensure compliance with FDA regulations and industry standards (e.g., 21 CFR Part 11, IEC 62304, ISO 13485).
• Own the quality approval process for software components, including documentation review and final release approvals.
• Act as the subject matter expert (SME) and work with the software product team to maintain, refine and improve the processes (policies,standard operating procedures (SOPs),and supporting documentation) for this area of the quality system.
• Partner with the software engineering team to implement andmaintaina robust software quality management system.
• Establish yourself as a trusted advisor to the Enterprise Applications team, with a problem-solving approach and a willingness to listen to the engineers and ensure the processes and documentation align with current regulations and best practices.
• Support projects with the IT Engineering team to automate documentation processes based on agreed project plans.
• Support the ITandEngineering teams following established service level agreements (SLA’s) and tracking key performance indicators(KPI’s).
• Communicate project and compliance issues to Quality Systems Management and provide solutions to mitigate potential risks
• Develop and support the teams that execute validation protocols, test scripts, and traceability matrices to ensure software functionality, reliability, and regulatory compliance.
• Provideexpertisein risk management for software risk assessments.
• Lead internal and external quality audits and investigations related to software validation and compliance.
• Collaborate with cross-functional teams, including regulatory, engineering, and operations, to support overall non-product software lifecycle management.
• Supports
  
  QA department todeterminedocumentationneeds.
  
  Establish and improve necessary document templates and guide staff to support project needs andmaintainsite compliance with good documentation practices andc
  
  GxPdata integrity requirements.
• Stayup to datewith evolving FDA, ISO, and other regulatory requirements forproductsoftware quality and validation.

• Bachelor's degree inlife sciences, engineering, or math preferred; or equivalent combination of education and experience.
• 5+ years ofquality experience in the pharmaceutical, biotech, or medical device industries.
• 3+years of experience in non-product software validation within an FDA-regulated environment and experience with releasing softwareproductin multiple regulated geographies.

• Project management tracking and trending experience preferred.
• Experience with all aspects of the non-product software validation processin a regulated industry.
• Strong understanding of FDA regulations, ISO 13485, and 21 CFR Part 11.
• Experience with auditor interaction in internal quality audits, regulatory inspections, and nonconformance investigations.
• Experience with agile practices in non-product software validation and lifecycle management.
• Ability to work independently with little oversight; self-starter, action oriented.
• Demonstrated ability to develop andoverseeexecution of product software validation plans and…